Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems. Aescul
FDA device recall Z-3014-2011 · posted 2011-08-12 · Terminated
Recall details
- Recalling firm
- Aesculap Inc
- Reason for recall
- Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.
- Action taken
- 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) 984-9300.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 149
- Distribution
- Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.
- Date initiated
- 2011-07-19
- Date posted
- 2011-08-12
- Date terminated
- 2013-03-19
- Location
- Center Valley, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| METHA HIP SYSTEM (K071916) | Aesculap Implant Systems, Inc. | 2008-06-02 |