Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. Shoulder replacement surgery.
FDA Recall Z-0177-2010 · Posted 2009-11-12
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHSD
Date Initiated2009-09-17
Date Terminated2009-12-22
Product Quantity12
Reason for Recall
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
Firm Action
Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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