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.

251–275 of 875

  • HighFDA (Devices)·Z-0538-2019·2018-12-12

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product sterility.

    Product
    Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2019·2018-12-12

    Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise

    Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.

    Product
    Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling eight units of the Vanguard Knee System because the outer carton labels do not match the inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0495-2019·2018-11-28

    Zimmer Biomet Recalls Vanguard Knee System Due to Label Mismatch

    Zimmer Biomet is recalling 8 units of Vanguard Knee System femoral components because outer carton labels do not match inner sterile packaging labels.

    Product
    Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0448-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0454-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Issue

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0451-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Malfunction

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0450-2019·2018-11-21

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Set Screw Defect

    Zimmer Biomet is recalling 2,163 Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0398-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 6,180 units of the RapidFlap SpinDown Clamp because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0395-2019·2018-11-14

    Zimmer Biomet RapidFlap SpinDown Clamp Recalled for Assembly Error

    Zimmer Biomet is recalling 23,726 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0397-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 3,246 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The device is used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0396-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling 11,580 RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The devices are used to re-attach bone flaps after craniotomy.

    Product
    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0393-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamp Due to Assembly Error

    Zimmer Biomet is recalling 12,825 units of the RapidFlap System 12mm SpinDown Clamp because the nut was assembled incorrectly. The defect affects sterile clamps used for craniotomy bone flap re-attachment.

    Product
    Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2019·2018-11-14

    Zimmer Biomet Recalls RapidFlap SpinDown Clamps Due to Assembly Error

    Zimmer Biomet is recalling RapidFlap SpinDown Clamps because the nut was assembled incorrectly. The defect affects 11,736 units distributed worldwide.

    Product
    Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-attachment of the bone flap after a craniotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2019·2018-11-14

    Zimmer Biomet Recalls StageOne Hip Cement Spacer Molds

    Zimmer Biomet is recalling 72 units of StageOne Hip cement spacer molds due to a potential for comingling of 43MM and 51MM sizes.

    Product
    StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0286-2019·2018-11-07

    Zimmer Biomet Recalls OsteoGen Bone Growth Stimulators for Cleanliness Issues

    Zimmer Biomet is recalling 4,879 OsteoGen Implantable Bone Growth Stimulators because the company could not ensure product cleanliness parameters were consistently met.

    Product
    EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0287-2019·2018-11-07

    Zimmer Biomet Recalls SpF PLUS-Mini Spinal Fusion Stimulators for Cleanliness Issues

    Zimmer Biomet is recalling SpF PLUS-Mini implantable spinal fusion stimulators because the company lacked adequate validation to ensure product cleanliness parameters were consistently met.

    Product
    SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0152-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 60 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 31 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
    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.