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U.S. Department of Health and Human Services

Class 2 Device Recall Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Sho

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 Class 2 Device Recall Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Shosee related information
Date Initiated by FirmJuly 19, 2011
Date PostedAugust 12, 2011
Recall Status1 Terminated 3 on March 19, 2013
Recall NumberZ-3014-2011
Recall Event ID 59463
510(K)NumberK071916 
Product Classification Prosthesis, Hip, Semi-constrained, - Product Code LZO
ProductMetha(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
Code Information Part Numbers: NC077K, NC078K, NC079K, NC087K, NC088K, NC089K, NC097K, NC098K, and NC099K)  Lot Numbers: All distributed lot numbers.
Recalling Firm/
Manufacturer		 Aesculap Inc
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information ContactLisa M. Boyle
800-258-1946
Manufacturer Reason
for Recall		Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionAESCULAP 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.
Quantity in Commerce149
DistributionNationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LZO
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