The Recall Desk

Hazard

Surgical Complication recalls

249 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
249
Critical
3
Severe
37
Most recent
2026-07-01

Of the 249 surgical complication recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 37 (15%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all surgical complication recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

51–75 of 249

  • HighFDA (Devices)·Z-2050-2021·2021-07-21

    EcoFit Cementless Acetabular Cup Plugs May Loosen During Hip Surgery

    Central hole cover plugs on EcoFit cementless acetabular cups may come loose during surgical implantation, potentially extending operation time or requiring revision surgery. Fifty-one units in Florida and Texas are affected.

    Product
    EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2987-2020·2020-09-30

    LivaNova Recalls Perceval Single Use Accessory Kits Due to Collapse Failure

    LivaNova is recalling specific lots of Perceval Single Use Accessory Kits because the Dual Collapser component may fail to reduce the heart valve diameter during implantation.

    Product
    Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2828-2020·2020-08-26

    NobelReplace Dental Implant Recall Due to Incorrect Measurement Labeling

    Nobel Biocare is recalling 188 NobelReplace dental implants because the cap label incorrectly lists measurements as 5.0x8mm instead of the actual 4.3x10mm.

    Product
    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2611-2020·2020-07-22

    Medtronic Bone Void Filler Recalled for Potential Failure to Set Properly

    Skeletal Kinetics is recalling Medtronic Bone Void Filler kits that may not maintain setting characteristics, potentially increasing surgical time or causing bone formation issues.

    Product
    MEDTRONIC BONE VOID FILLER, SMALL. Product Number: C07A, UDI: 813845020504 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2596-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits

    Skeletal Kinetics is recalling 41 units of Acumed Impact 5CC bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    ACUMED IMPACT 5CC. Product Number: 65-0105-S, UDI: 813845020252 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traum
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2601-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    CRANIOSCULPT FLOW, 10CC. Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2617-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2612-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation EX Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation EX bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION EX, 3CC, IMPACT FORMULA. Product Number: 390-0203, UDI: 813845020030 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2592-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits

    Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2633-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Kits

    Skeletal Kinetics is recalling 27 units of Craniosculpt bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, OUS, 10CC. Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2630-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD RENU FLOW Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD RENU FLOW bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    SKAFFOLD RENU FLOW, 10CC. Product Number: SKMA-FL10, UDI: 813845020856 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2594-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Callos Bone Void Filler Kits

    Skeletal Kinetics is recalling Acumed Callos bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Bone Void Filler Due to Setting Defects

    Skeletal Kinetics is recalling 51 units of Craniosculpt bone void filler because the product may not maintain its setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects creat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2020·2020-07-22

    Skeletal Kinetics Recalls SKAFFOLD CMF Impress Bone Void Filler Kits

    Skeletal Kinetics is recalling SKAFFOLD CMF Impress bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects creat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2602-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    CRANIOSCULPT FLOW, CAN, 5CC. Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation RMX Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation RMX bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from trau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2622-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovationex Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovationex 5cc bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects cre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2020·2020-07-22

    Skeletal Kinetics Recalls Acumed Impact Bone Void Filler Kits

    Skeletal Kinetics is recalling 40 Acumed Impact bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    ACUMED IMPACT 10CC. Product Number: 65-0110-S, UDI: 813845020269 - Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling 70 units of Craniosculpt Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created fro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2020·2020-07-22

    Skeletal Kinetics Recalls Craniosculpt C Bone Void Filler Kits

    Skeletal Kinetics is recalling Craniosculpt C bone void filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from trau
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2020·2020-07-22

    Skeletal Kinetics Recalls Ossilix Bone Void Filler Kits Due to Setting Defects

    Skeletal Kinetics is recalling 60 units of Ossilix MP Fil bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life.

    Product
    EXACTECH OSSILIX MP FIL, 10CC. Product Number: 662-02-10, UDI: 813845021051 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects create
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2619-2020·2020-07-22

    Skeletal Kinetics Recalls Osteovation Bone Void Filler Kits

    Skeletal Kinetics is recalling Osteovation bone void filler kits because they may not maintain setting characteristics for the labeled shelf-life, potentially increasing surgical time or causing bone formation issues.

    Product
    OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects crea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2020·2020-07-22

    Medtronic Bone Void Filler Recalled for Potential Failure to Set

    Skeletal Kinetics is recalling Medtronic Bone Void Filler kits because they may not maintain setting characteristics for the labeled shelf life, potentially increasing surgical time or causing bone formation issues.

    Product
    MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2627-2020·2020-07-22

    Skeletal Kinetics Recalls Skaflow Flow Bone Void Filler Kits

    Skeletal Kinetics is recalling Skaflow Flow bone void filler kits because they may not maintain setting characteristics for the labeled shelf life.

    Product
    SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseou
    Category
    Medical Device
    Distribution
    Distributed nationwide