Z-1344-06
Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no...
Zimmer GmbH / initiated 2006-06-26 / Terminated / root cause: packaging
Zimmer Inc. began a recall of Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. (00625006520) on . The reason FDA records is "Lack of assurance of sterility, as the sterile barrier packaging may have been compromised". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1344-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Zimmer Bone Screw, self tapping, 6.5 mm dia., 20 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6250-65-20 (00625006520).
- Product code
- HWC Screw, Fixation, Bone
- Reason for recall
- Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
- Root cause tag
- packaging
- FDA root cause
- Other
- Action
- 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.
- Quantity in commerce
- 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.
- Product codes and lots
- Lot 60330168.
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