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U.S. Department of Health and Human Services

Class 2 Device Recall Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm

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  Class 2 Device Recall Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm see related information
Date Initiated by Firm February 24, 2015
Date Posted March 30, 2015
Recall Status1 Terminated 3 on September 21, 2015
Recall Number Z-1352-2015
Recall Event ID 70579
510(K)Number K131548  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
Code Information Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026,  9124016, 9124027, 8918563  
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 guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments.
FDA Determined
Cause 2		 Component design/selection
Action DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450.
Quantity in Commerce 131
Distribution US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
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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