Recall Z-1496-2014 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer, Inc.
TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
| Date | Apr 24, 2014 (initiated Apr 1, 2014) |
| Status | Terminated |
| Reason | The shell was missing the locking ring. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" notification dated April 2014 to their consignees. The notification included product description, product issue, health risks, and consignee responsibilities (including directions on how to return the affected product). The consignees were instructed to locate all products from lot 62490588 and quarantine them immediately; carry out a physical count of all affected product; complete and return the Inventory Return Certification Form via email to: corporatequality.postmarket@zimmer.com; return the recalled product, and notif |
| Quantity | 17 units |
| Distribution | Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021891 | ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM Zimmer, Inc., Sep 5, 2002 |