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U.S. Department of Health and Human Services

Class 2 Device Recall 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM Sterile

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  Class 2 Device Recall 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM Sterile see related information
Date Initiated by Firm October 29, 2014
Date Posted November 14, 2014
Recall Status1 Terminated 3 on December 18, 2015
Recall Number Z-0219-2015
Recall Event ID 69685
510(K)Number K011857  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Code Information part number: 456.316S, lot number: 7782247
Recalling Firm/
Manufacturer		 Synthes, Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Customer Support
610-719-5000
Manufacturer Reason
for Recall		 The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
FDA Determined
Cause 2		 Employee error
Action An urgent medical device recall notice, dated October 29, 2014, was sent to end users that identified the product, problem and action to be taken. Customers were instructed to return the device to Synthes along with completing the verification section of the notice.
Quantity in Commerce 6
Distribution US Distribution in the states of: AK, FL, OH, OK, and TX.
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 = HSB and Original Applicant = SYNTHES (USA)
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