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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer HGP II Acetabular Components Bone Screw

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  Class 2 Device Recall Zimmer HGP II Acetabular Components 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-1347-06
Recall Event ID 35784
Product Classification bone screw - Product Code HWC
Product Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 40 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-40 (00662406540).
Code Information Lots 42330300, 56131900, 71517900, 73057500 and 77838200.
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.