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U.S. Department of Health and Human Services

Class 2 Device Recall Helical Blade Inserter for Trochanteric Fixation NailADVANCED (TFNA)

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  Class 2 Device Recall Helical Blade Inserter for Trochanteric Fixation NailADVANCED (TFNA) see related information
Date Initiated by Firm June 10, 2015
Date Posted July 16, 2015
Recall Status1 Terminated 3 on August 18, 2016
Recall Number Z-2091-2015
Recall Event ID 71492
510(K)Number K131548  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
Code Information Part Number Lot Numbers 03.037.024 T102759 
Recalling Firm/
Manufacturer
Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact Customer Support
610-719-6500
Manufacturer Reason
for Recall
The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).
FDA Determined
Cause 2
Process control
Action A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.
Quantity in Commerce 32
Distribution Nationwide Distribution.
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) PRODUCTS, LLC
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