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Terminated

Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.

FDA Recall Z-0210-2007 · Posted 2006-11-22

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHWT
Date Initiated2006-10-19
Date Terminated2007-12-05
Product Quantity50

Reason for Recall

The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.

Firm Action

The firm''s sales force was notified via recall letter dated 10/19/06 to secure product from customer accounts and to return it to Zimmer.

Root Cause

Other

Distribution Pattern

Nationwide and Australia.

Official Source

View FDA Recall →

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

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