The Recall Desk

Hazard

Implant Loosening recalls

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

What the numbers show

Total
20
Critical
0
Severe
4
Most recent
2025-02-12

Of the 20 implant loosening recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (20%) 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 implant loosening 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.

1–20 of 20

  • HighFDA (Devices)·Z-1111-2025·2025-02-12

    Temporary Titanium Abutments May Fracture in Dental Implants

    DDS Lab temporary titanium abutments may have been installed in some dental implant restoration cases instead of definitive abutments. The components may fracture, risking restoration loosening, oral tissue injury, and aspiration.

    Product
    Temporary Titanium Abutments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2024·2024-05-01

    Hip prosthesis shells recalled for manufacturing deburring defect

    Howmedica Osteonics Corp. is recalling TRIDENTII PSL CLUSTER52E hip prostheses with excessive deburring on the acetabular shell edge, which could affect implant stability. Three units were distributed nationwide and internationally.

    Product
    TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-52E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0726-2024·2024-01-24

    PRIMA TT Shoulder Implant Baseplates Recalled for Manufacturing Defect Risk

    PRIMA TT shoulder implant baseplates are being recalled by Limacorporate due to manufacturing defects in the baseplate peripheral holes that could cause the implant to loosen or the screw to move.

    Product
    PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1384-2023·2023-04-19

    Knee Patella Drills Recalled for Incorrect Diameter Markings

    Encore Medical is recalling EMPOWR Knee Patella drills due to reversed diameter markings that could cause incorrect drill selection during surgery, leading to implant loosening or bone fracture.

    Product
    EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1447-2022·2022-07-27

    Aesculap S4 Cervical Cross Connector Recalled Due to Clamping Force Defect

    Aesculap Implant Systems is recalling the S4 Cervical Cross Connector L 33-42mm due to insufficient clamping force that may cause connector movement or microparticle abrasion in spinal fusion implants.

    Product
    AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2512-2021·2021-09-29

    Univation X Knee Implant Devices Recalled Due to Loosening Risk

    Aesculap Implant Systems is recalling Univation X System knee implant devices (all lots, nationwide) because the implants may loosen, potentially requiring revision surgery. No injuries have been reported.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL488 UNIVATION F MENISCAL COMP.T1 RM/LM 10MM; NL489 UNIVATION F MENISCAL COMP.T2 RM/LM 10MM; NL490 UNIVATION F MENISCAL COMP.T3 RM/LM 10MM; NL491 UNIVATION F MENISCAL COMP.T4 RM/LM 10MM; NL492 UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2021·2021-09-29

    Univation X Knee Implant Devices Recalled for Risk of Loosening

    Aesculap Implant Systems is recalling Univation X System knee implant devices nationwide due to potential loosening. The malfunction could require revision surgery.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION F MENISCAL COMP.T2 RM/LM 11MM; NL496 UNIVATION F MENISCAL COMP.T3 RM/LM 11MM NL497 UNIVATION F MENISCAL COMP.T4 RM/LM 11MM NL498 UNIVATION F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2511-2021·2021-09-29

    Univation X System knee implants recalled for loosening risk

    Aesculap Implant Systems is recalling Univation X System knee implants because they may loosen, potentially requiring additional surgery. The recall affects devices distributed nationwide.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL482 UNIVATION F MENISCAL COMP.T1 RM/LM 9MM; NL483 UNIVATION F MENISCAL COMP.T2 RM/LM 9MM; NL484 UNIVATION F MENISCAL COMP.T3 RM/LM 9MM; NL485 UNIVATION F MENISCAL COMP.T4 RM/LM 9MM; NL486 UNIVATION F ME
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2514-2021·2021-09-29

    Univation X System Knee Implants Recalled for Loosening Risk

    Aesculap Implant Systems recalls Univation X System knee implants nationwide due to risk of loosening that could require revision surgery. All lots are affected.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATION XF TIBIA CEMENTED T2 RM; NO158Z AS UNIVATION XF TIBIA CEMENTED T3 RM; NO159Z AS UNIVATION XF TIBIA CEMENTED T4 RM; NO160Z AS UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2021·2021-09-29

    Univation X System Knee Implant Devices Recalled for Loosening Risk

    Aesculap Implant Systems is recalling Univation X System knee implant devices because they may loosen, potentially requiring revision surgery. All lots distributed in the US are affected.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATION XF FEMUR CEMENTED F2 RM; NO182Z AS UNIVATION XF FEMUR CEMENTED F3 RM; NO183Z AS UNIVATION XF FEMUR CEMENTED F4 RM; NO184Z AS UNIVATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2516-2021·2021-09-29

    Univation X System Tray knee implants recalled for loosening defect

    Aesculap is recalling Univation X System Tray knee implants due to a loosening defect that may require revision surgery. All lots nationwide are affected.

    Product
    Univation X System Tray Sysem knee implant devices as follows: Tray Number/Set Name/Set Number NM1090R Navigation Set ST0560; NM1092R + NM1095R + NM1096R (Tray insert to NM1095R) univation XF ST0540; NM1093R univation XF OPT ST0544
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2509-2021·2021-09-29

    Univation X knee implant devices recalled for potential loosening

    Aesculap Implant Systems is recalling Univation X System knee implants nationwide due to potential loosening that may require revision surgery.

    Product
    Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F MENISCAL COMP.T2 RM/LM 7MM; NL472 UNIVATION F MENISCAL COMP.T3 RM/LM 7MM NL473 UNIVATION F MENISCAL COMP.T4 RM/LM 7MM NL474 UNIVATION F M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1812-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism May Fail Intraoperatively

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0242 Insignia, ACP, 2-Level, 42 mm, Rx Only, Non-Sterile, UDI: (01)00190376268415
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2018·2018-02-28

    Synthes LCP Drill Sleeve Recall Due to Connection and Alignment Issues

    Synthes, Inc. is recalling LCP Drill Sleeve 1.5 Drill Bits because they may fail to attach to plates, potentially causing surgical delays or off-center drilling.

    Product
    LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1917-2016·2016-06-15

    Zimmer Biomet Recalls Persona Trabecular Metal Tibial Plate Instruments

    Zimmer Biomet is recalling specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets due to incidents of radiolucent lines and loosening in implants.

    Product
    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-0114-2014·2013-11-06

    Synthes Sternal Zip Flex System Recalled for Implant Cutting Risk

    Synthes USA HQ, Inc. is recalling 319 units of the Sternal Zip Flex System because the application instrument may cut the implant, leading to loosening.

    Product
    Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1156-2013·2013-05-01

    Orthopedic Alliance Recalls Blue & Gold Spine System Implants

    Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.

    Product
    Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0541-2013·2012-12-26

    Zimmer Persona Knee System Recalled for Tibial Perforation Risk

    Zimmer, Inc. is recalling Persona knee system tibia implants and tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0546-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Drill Guide

    Zimmer, Inc. is recalling 94 units of the Persona Tibial Drill Guide to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0551-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide