Zimmer M/DN Intramedullary Fixation 4.5 dia. cortical screw, 3.5 mm hex head, 65 mm length, 22-13-5 stainless steel, ste
FDA device recall Z-1337-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
- Action taken
- Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
- Root cause
- Other
- Status
- Terminated
- Product code
- NDJ
- Quantity affected
- 310 total for all catalog numbers
- Distribution
- Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
- Date initiated
- 2006-06-26
- Date posted
- 2006-08-03
- Date terminated
- 2007-12-05
- Location
- Warsaw, IN
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