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Terminated

Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, 15 mm diameter, 130 mm length, non-sterile, catalog no. 4309-15-13 (00-4309-015-13).

FDA Recall Z-1278-06 · Posted 2006-07-27

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHWT
Date Initiated2006-06-16
Date Terminated2007-12-05
Product Quantity324 total

Reason for Recall

During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.

Firm Action

U.S. and international distributors were notified of the recall via letter dated 6/30/2006 to check customer inventories and to return recalled product to the firm. Trial implants were redesigned and reworked to eliminate the problem.

Root Cause

Other

Distribution Pattern

Nationwide and worldwide including Australia, Canada, Germany, Italy and Spain.

Official Source

View FDA Recall →

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

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