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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer ITST intertrochanteric/subtrochanteric Intramedullary fixation Rod and Accessories

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 Class 2 Device Recall Zimmer ITST intertrochanteric/subtrochanteric Intramedullary fixation Rod and Accessoriessee related information
Date Initiated by FirmMay 04, 2016
Date PostedMay 16, 2016
Recall Status1 Terminated 3 on July 05, 2017
Recall NumberZ-1681-2016
Recall Event ID 73981
510(K)NumberK143321 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductITST intertrochanteric/subtrochanteric fixation 4.5 mm diameter cortical screw, 3.5 mm hex head, 57 mm length 00225305745
Code Information LOT: 63275969 
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
ActionAll 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 Commerce50
DistributionWorldwide 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 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 = HSB
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