Recall Z-0376-2021 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Biomet, Inc.
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
| Date | Sep 24, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL AND NOTICE OF US FIELD DISCONTINUATION letter to Distributors. Risk Manages, Physicianson/ 9/24/20 stating reason for recall, heath risk and action to take: 1.Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to Corporat |
| Quantity | 412 units total |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.