Recall Z-3014-2011 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Aesculap Inc
Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aesculap AG. Intended to replace a hip joint
| Date | Aug 12, 2011 (initiated Jul 19, 2011) |
| Status | Terminated |
| Reason | Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter. |
| Root cause | Unknown/Undetermined by firm |
| Action | AESCULAP Implant Systems sent an "Important Recall Notification" letter dated to all affected customers. The informed customers of a complaint received where fractured CoCR adapter was found and to return any affected product to the firm. The reason for the fracture is currently under investigation. While the firm is trying to determine the root cause of the fracture, they will be offering the Metha non-modular short hip implants to their customers. Customers are asked to return an Inventory Sheet to AESCULAP. For additional information on this recall call (610) 984-9239 or (610) 984-93 |
| Quantity | 149 |
| Distribution | Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071916 | METHA HIP SYSTEM Aesculap Implant Systems, Inc., Jun 2, 2008 |