Medical device recalls

39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.

2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-28
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 55 mm Number: 00-8065-652-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-32
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-28
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 53 mm Number: 00-8065-650-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-32
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-28
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm Number: 00-8065-648-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-32
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-28
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 49 mm Number: 00-8065-646-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-28
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 47 mm Number: 00-8065-644-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 45 mm Number: 00-8065-642-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, 10 degree inclined face, O.D. Cup with Spacers, 43 mm Number: 00-8065-640-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-32
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-28
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-32
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-28
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-26
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 59 mm Number: 00-8065-556-22
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 adverse tissue reactions.
2020-11-11FDA-DeviceZimmer Biomet, Inc.Class II
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 57 mm Number: 00-8065-554-32
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 adverse tissue reactions.

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