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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Herbert Cannulated Bone Screw System Bone Screw

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 Class 2 Device Recall Zimmer Herbert Cannulated Bone Screw System Bone Screwsee related information
Date Initiated by FirmJune 26, 2006
Date PostedAugust 03, 2006
Recall Status1 Terminated 3 on December 05, 2007
Recall NumberZ-1348-06
Recall Event ID 35784
510(K)NumberK792022 
Product Classification bone screw - Product Code HWC
ProductZimmer 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).
Code Information Lots 15550200 and 19495400.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-846-4637
Manufacturer Reason
for Recall		Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
FDA Determined
Cause 2		Other
ActionHospital 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 Commerce310 total for all catalog numbers
DistributionWorldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HWC
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