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Terminated

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

FDA Recall Z-3014-2011 · Posted 2011-08-12

Recalling FirmAesculap Inc
Recall StatusTerminated
Product CodeLZO
Date Initiated2011-07-19
Date Terminated2013-03-19
Product Quantity149

Reason for Recall

Aesculap Implant Systems received a notification from the manufacturer, Aesculap, AG of a fractured CoCr neck adapter.

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) 984-9300.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

Nationwide (USA) Distribution including the states of AL, FL, GA, MD, NM, NY, OK, and TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071916METHA HIP SYSTEMAesculap Implant Systems, Inc. · 2008-06-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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