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
Reported: November 11, 2020 Initiated: September 24, 2020 #Z-0362-2021
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 412 units total
- Distribution
- US Nationwide
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zimmer Biomet, Inc.. Units affected: 412 units total.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2020. Severity: Moderate. Recall number: Z-0362-2021.
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