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