Date Initiated by Firm |
April 18, 2013 |
Date Posted |
September 18, 2013 |
Recall Status1 |
Terminated 3 on March 30, 2015 |
Recall Number |
Z-2243-2013 |
Recall Event ID |
64406 |
510(K)Number |
K970733
|
Product Classification |
Fixation Pin - Product Code HTY
|
Product |
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device. |
Code Information |
Part Number 450.851S, Lot Number 7065061 |
Recalling Firm/ Manufacturer |
Synthes USA HQ, Inc. 1302 Wrights Ln E West Chester PA 19380-3417
|
For Additional Information Contact |
Synthes Customer Service 610-719-5000
|
Manufacturer Reason for Recall |
Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested. |
Quantity in Commerce |
1 |
Distribution |
US distribution to MA. |
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 = HTY and Original Applicant = SYNTHES (USA)
|