Recall Z-0992-2018 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer Biomet, Inc.
DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
| Date | Jun 30, 2017 |
| Status | Terminated |
| Reason | Product may contain the presence of melted sterile packaging upon opening. |
| Root cause | Packaging process control |
| Action | On June 2, 2017 an URGENT Medical Recall Letter was issued to customers regarding affected product(s). The letter requests customers to review the content and notify affected personnel of the recall. Assist the sales representative in quarantining affected product, which will be removed and returned to recalling firm and then replaced. All customers who may have received product from distributors are to be notified. Questions or concerns can be directed to 1-574-372-4847. |
| Quantity | 30 |
| Distribution | US in the state of Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131684 | BIOLOX(R) DELTA CERAMIC HEADS Biomet, Inc., Oct 10, 2013 |