Recall Z-2033-2014 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer, Inc.
Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes: 5.0, 7.5, 9.0, 10.0, 11.0, 12.5, 13.5, 15.0, 11.25, 17.25, 20.0 & 22.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
| Date | Jul 10, 2014 (initiated May 23, 2014) |
| Status | Terminated |
| Reason | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. |
| Root cause | Packaging |
| Action | Zimmer sent an Medical Device Recall Letter on June 4, 2014, to their Distributors. On June 9, 2014, Zimmer sent Medical Device Recall Letters to the physicians. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. Locate all products from the affected lots and quarantine them immediately, if not previously done so per the May 23, 2014 Notice of Suspension of Loaner Pool. 2. Confirm the physical count of all affected product in loaner pool in your territory and complete the Confirmation of Loaner Pool Inventory and Re |
| Quantity | 1487 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, China, Europe, India, Japan, Korea and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032726 | ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES Zimmer, Inc., Oct 22, 2003 |