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
- Company
- Aesculap Inc
- Recall Initiated
- July 19, 2011
- Posted
- August 12, 2011
- Terminated
- March 19, 2013
- Recall Number
- Z-3014-2011
- Quantity
- 149
- Firm Location
- Center Valley, PA
Reason for Recall
Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.
Distribution
Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.
Lot / Code Info
Part Numbers: NC077K, NC078K, NC079K, NC087K, NC088K, NC089K, NC097K, NC098K, and NC099K) Lot Numbers: All distributed lot numbers.
Root Cause
Unknown/Undetermined by firm
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.