Recall Z-1219-2015 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer, Inc.
Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
| Date | Feb 27, 2015 (initiated Feb 5, 2015) |
| Status | Terminated |
| Reason | PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. |
| Root cause | Process control |
| Action | Zimmer sent an URGENT MEDICAL DEVICE RECALL - Lot Specific letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. Locate and remove from inventory the affected products identified above. 3. Return any affected product with missing PMMA coating per the PER process 4. Return the Notification Acknowledgment Form (Attachment 1) to corporatequality.postmarket@zimmer.com. 5. Please notify Zi |
| Quantity | 1 unit |
| Distribution | US Distribution to the state of TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101296 | ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS Zimmer, Inc., Jul 30, 2010 |