Zimmer Herbert Cannulated Bone Screw System Bone Screw, 4.5 mm dia., 25 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 47-1155-25-05 (47115502505).
FDA Recall Z-1348-06 · Posted 2006-08-03
Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2006-06-26
Date Terminated2007-12-05
Product Quantity310 total for all catalog numbers
Reason for Recall
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.