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Terminated

Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK

FDA Recall Z-0316-2008 · Posted 2007-12-15

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2007-06-28
Date Terminated2008-03-17
Product Quantity62 (total for Z-0316-0317-2008)

Reason for Recall

Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound

Firm Action

Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer.

Root Cause

Process control

Distribution Pattern

Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.

Official Source

View FDA Recall →

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

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