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Terminated

Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.

FDA Recall Z-0178-2010 · Posted 2009-11-12

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.

K041549ZIMMER TRABECULAR METAL HUMERAL STEMZimmer, Inc. · 2004-09-01

Official Source

View FDA Recall →

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

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