Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
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20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Produ
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Produ
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Prod
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Prod
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A sin
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-22
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-22
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-02
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
December 12, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-0
Hazard: Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
November 28, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
Hazard: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
November 28, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Hazard: Label on the outer carton or the patient labels does not match label on the inner sterile packaging
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail 130 Deg 12x165mm, Item Number 816812165 The Affixus Hip Fracture Nail System, comprised of
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail 125 Deg 12x165mm, Item Number 816712165 The Affixus Hip Fracture Nail System, comprised of
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail 125 Deg 10x165mm, Item Number 816710165 The Affixus Hip Fracture Nail System, comprised of
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail Left 125 Deg 9x165mm, Item Number 816709165 The Affixus Hip Fracture Nail System, comprise
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail Left 130 Deg 11x300mm, Item Number 814611300 The Affixus Hip Fracture Nail System, compris
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail Left 125 Deg 11x300mm, Item Number 814411300 The Affixus Hip Fracture Nail System, compris
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 21, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Affixus Hip Fracture Nail Left Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of
Hazard: The set screw is not able to advance or reverse from the original position in the nail.
November 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposabl
Hazard: There is a potential for comingling of the 43MM and 51 MM molds
November 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1040-12 Used for the re-
Hazard: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
November 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System 20MM RapidFlap SpinDown Clamp Ref Number: 75-1040 Used for the re-attachment
Hazard: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
November 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the r
Hazard: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
November 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp Ref Number: 75-1030 Used for the re-attachment
Hazard: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
November 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System, 12MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1020-12 Used for the re-a
Hazard: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
November 14, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Biomet Microfixation RapidFlap System 12mm SpinDown Clamp, sterile Ref Number: 75-1020 Used for the re-attachment of t
Hazard: Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
November 7, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indi
Hazard: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.