Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; REF 7712-35-02, Zimme
FDA device recall Z-0317-2008 · posted 2007-12-15 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound
- Action taken
- 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
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 62 (total for Z-0316-0317-2008)
- Distribution
- Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.
- Date initiated
- 2007-06-28
- Date posted
- 2007-12-15
- Date terminated
- 2008-03-17
- Location
- Warsaw, IN
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