Recall Z-2216-2010 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of the pelvic antebulum in revision total hip arthroplasty surgery.
| Date | Aug 12, 2010 (initiated Apr 6, 2010) |
| Status | Terminated |
| Reason | The firm has determined that some of the packages could develop a breach of the seal in the sterile barrier pouches. |
| Root cause | Packaging |
| Action | The firm sent an "Urgent Device Removal" letter dated 4/6/2010. The consignees were instructed to inventory the products on hand and return the recalled product to the manufacturer. More information is available at 1-800-613-6131. |
| Quantity | 1,972 all products |
| Distribution | US, Germany, Brazil, Singapore, Canada, Australia, England, India, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061067 | TRABECULAR METAL ACETABULAR AUGMENTS Zimmer Trabecular, May 25, 2006 |