Medical DeviceDec 30, 2020
Zimmer Biomet Spinal Rod Cutter, Item number 00392500200 recall — FDA Z-0696-2021
Device has the potential for fracture during use.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Recall history in this database
Classification mix: Class II: 103.
Medical DeviceDec 23, 2020
Zimmer Biomet Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System recall — FDA Z-0570-2021
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm recall — FDA Z-0344-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 recall — FDA Z-0368-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm recall — FDA Z-0394-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 recall — FDA Z-0363-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm recall — FDA Z-0328-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 recall — FDA Z-0370-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 recall — FDA Z-0386-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm recall — FDA Z-0348-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm recall — FDA Z-0325-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 recall — FDA Z-0374-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm recall — FDA Z-0396-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 recall — FDA Z-0357-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 recall — FDA Z-0371-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm recall — FDA Z-0327-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 recall — FDA Z-0381-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm recall — FDA Z-0351-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22mm recall — FDA Z-0333-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm recall — FDA Z-0346-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 recall — FDA Z-0364-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 recall — FDA Z-0388-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 recall — FDA Z-0362-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceNov 11, 2020
Zimmer Biomet ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm recall — FDA Z-0352-2021
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for…
Class IIFDA: TerminatedZimmer Biomet, Inc.
Understanding this recall history
This page summarizes recall records in which the official source identifies Zimmer Biomet, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.