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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Bone Screw

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  Class 2 Device Recall Zimmer Bone Screw see related information
Date Initiated by Firm June 26, 2006
Date Posted August 03, 2006
Recall Status1 Terminated 3 on December 05, 2007
Recall Number Z-1344-06
Recall Event ID 35784
510(K)Number K934765  
Product Classification bone screw - Product Code HWC
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).
Code Information Lot 60330168.
Recalling Firm/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
Manufacturer Reason
for Recall
Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HWC and Original Applicant = ZIMMER, INC.