The Recall Desk

Manufacturer

Zimmer Biomet, Inc.

875 recalls in our database name Zimmer Biomet, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
875
Critical
0
Severe
129
Most recent
2020-12-30

Of the 875 recalls from Zimmer Biomet, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 129 (15%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

601–625 of 875

  • SevereFDA (Devices)·Z-0774-2018·2018-03-07

    Zimmer Biomet Recalls Antegrade Femoral Nail Instrument Kits

    Zimmer Biomet is recalling 337 Antegrade Femoral Nail Instrument Kits because a bolt may fracture during use, potentially affecting patients undergoing orthopedic surgery.

    Product
    14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2018·2018-03-07

    Zimmer Biomet Recalls Segmental System Distal Femur Components

    Zimmer Biomet is recalling 3,350 units of the Segmental System, ZSS Distal Femur, because the products exceeded tested weights, potentially compromising the sterile barrier.

    Product
    Zimmer Segmental System, ZSS Distal Femur. Sizes as follows: a. Size B-LT (Item No. 00585001201); b. Size B-RT (Item No. 00585001202); c. Size C-LT (Item No. 00585001301); d. Size C-RT (Item No. 00585001302) Components of the system are intended to replace the pro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2018·2018-03-07

    Zimmer Biomet Recalls Phoenix Antegrade Femoral Nail Connecting Bolts

    Zimmer Biomet is recalling 337 Phoenix Antegrade Femoral Nail Connecting Bolts because the bolt may fracture during insertion of the femoral nail.

    Product
    Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0722-2018·2018-03-07

    Zimmer Biomet Recalls Versys Hip Prostheses Due to Sterile Barrier Risk

    Zimmer Biomet is recalling 38,069 units of Versys 6 inch Beaded Full Coat Plus Hip Prostheses because weight issues may have compromised the sterile barrier.

    Product
    Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK (Item No. 00784302106); c. VERSYS 6 INCH BEADED FC 22X160MM STD BO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0818-2018·2018-03-07

    Zimmer Biomet Recalls Ziptight Ankle Fixation Devices Due to Missing Tip Protectors

    Zimmer Biomet is recalling 885 Ziptight Ankle Syndesmosis Fixation Devices because they were packaged without tip protectors.

    Product
    Ziptight Ankle Syndesmosis Fixation Device, Titanium Implant Titanium Implant for surgical repairs of soft tissue.
    Category
    Medical Device
    Distribution
    29 states
  • SevereFDA (Devices)·Z-0638-2018·2018-02-28

    ROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors

    Zimmer Biomet is recalling 16 ROSA Brain 3.0 Stereotaxic instruments because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0639-2018·2018-02-28

    Zimmer Biomet Recalls ROSA Spine Stereotaxic Instrument Due to Positioning Error

    Zimmer Biomet is recalling one ROSA Spine 1.0.2 Stereotaxic instrument because the robot arm may move to the wrong position during surgery.

    Product
    ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0673-2018·2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size. The components are intended for use in total knee arthroplasty.

    Product
    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0674-2018·2018-02-28

    Zimmer Biomet Recalls Vanguard Knee Implant Components Due to Labeling Error

    Zimmer Biomet is recalling 24 Vanguard Complete Knee System tibial bearings because they are labeled with the incorrect size.

    Product
    Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0628-2018·2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implants

    Zimmer Biomet is recalling 11 AGC 2000 LP Patella knee implants because they were over-molded, causing the outside diameter to not match the required specifications.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar Med, Model Number 150804. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2018·2018-02-21

    Zimmer Biomet Recalls G7 Dual Mobility Hip Liners Due to Labeling Error

    Zimmer Biomet is recalling 8 units of G7 Dual Mobility Liners because they are labeled as 44mm but may physically be 42mm liners.

    Product
    G7 DUAL MOBILITY LINER 44MM F Product Usage: Intended for use in hip arthroplasty cases which involves the removal of the damaged joint and tissues to be replaced with artificial prosthesis. The result of the procedure is to relieve pain and restore a sense of normal function
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0609-2018·2018-02-21

    Zimmer Biomet Recalls BlockAid Cut Resistant Surgical Glove Liners

    Zimmer Biomet is recalling BlockAid Cut Resistant Surgical Glove Liners because the product lacks sterility assurance. The recall affects 1,863 units distributed in 29 states and three countries.

    Product
    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0627-2018·2018-02-21

    Zimmer Biomet Recalls AGC 2000 LP Patella Knee Implant Devices

    Zimmer Biomet is recalling 28 AGC 2000 LP Patella knee implants because they were over-molded, leaving the outside diameter nonconforming to the print dimension.

    Product
    AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2018·2018-02-21

    Zimmer Biomet Recalls Persona Partial Knee System Impactor Pads

    Zimmer Biomet is recalling 1,275 Persona Partial Knee System instruments because the impactor pad may fracture during use.

    Product
    Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2018·2018-02-14

    Zimmer Biomet Recalls 1.0mm Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 1,524 non-sterile 1.0mm drill bits because a raw material anomaly may increase the risk of instrument fracture.

    Product
    DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0548-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification Gap

    Zimmer Biomet is recalling 1,517 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm lengths.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in gu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0547-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Design Verification

    Zimmer Biomet is recalling 6,290 units of M/DN Intramedullary Fixation Humeral Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guidin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0550-2018·2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 10,116 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0549-2018·2018-02-14

    Zimmer Biomet Recalls Humeral Guide Wire Ball Tip Due to Packaging Design Verification

    Zimmer Biomet is recalling 7,888 Humeral Guide Wire Ball Tip units because the previous packaging configuration lacks design verification for 70cm wires.

    Product
    Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wir
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2018·2018-02-14

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 1,631 units of Natural Nail System Tear Drop Guide Wires because the previous packaging configuration lacked design verification for 70cm wires.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during impla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0472-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may not be in the correct location, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent the set screw and sleeve assembly from staying in place.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Zimmer Biomet Holdings

medical device company

Country
United States
Founded
1927

Official website

Source: Wikidata (Q203552), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.