Recall Z-1260-2015 ยท LXH Orthopedic Manual Surgical Instrument
Synthes, Inc.
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyse
| Date | Mar 10, 2015 (initiated Feb 3, 2015) |
| Status | Terminated |
| Reason | The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN. |
| Root cause | Device Design |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated February 3, 2015, to all affected customers to alert them about the recall and explain the benefits and risks associated with removing this device from the market. It stated that the immediate removal of the product would prevent the performance of emergency surgery, thus DePuy Synthes is not requiring an immediate removal of affected product(s). DePuy Synthes is in the process of developing the replacement & recovery plan for indicated devices. Due to their current but temporary lack of replacement inventory, Synthes pro |
| Quantity | 1550 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.