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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Selftapping bone screw

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  Class 2 Device Recall Zimmer Selftapping bone screw see related information
Date Initiated by Firm May 04, 2016
Date Posted May 16, 2016
Recall Status1 Terminated 3 on July 05, 2017
Recall Number Z-1684-2016
Recall Event ID 73981
510(K)Number K934765  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Trilogy self-tapping bone screw
Bone screw 4.5x25 selftap 00625004525
Bone screw 4.5x50 selftap 00625004550
Bone screw 6.5x15 selftap 00625006515
Bone screw 6.5x20 selftap 00625006520
Bone screw 6.5x25 selftap 00625006525
Bone screw 6.5x30 selftap 00625006530
Code Information LOTS: 63284570 63284572 63284573 63187350 63225662 63272712 63296123 63301504 63204283 63209528 63259476 63257719 
Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
Manufacturer Reason
for Recall		 A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
FDA Determined
Cause 2		 Packaging change control
Action All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Quantity in Commerce 3893
Distribution Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
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 = LPH and Original Applicant = ZIMMER, INC.
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