Date Initiated by Firm | October 03, 2016 |
Date Posted | November 19, 2016 |
Recall Status1 |
Terminated 3 on July 06, 2017 |
Recall Number | Z-0637-2017 |
Recall Event ID |
75502 |
Product Classification |
Reamer - Product Code HTO
|
Product | 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile |
Code Information |
Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875. |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
|
For Additional Information Contact | 610-719-6500 |
Manufacturer Reason for Recall | The peel pouches for the affected reaming rods and extraction hooks are delaminating. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem. |
Quantity in Commerce | 1,951 units |
Distribution | Distributed Nationwide |
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.
|