Recall Z-0125-2016 ยท LXH Orthopedic Manual Surgical Instrument
Synthes (USA) Products LLC
Inserter for Titanium Elastic Nails (TEN), orthopedic device
| Date | Sep 3, 2015 |
| Status | Terminated |
| Reason | potential for mechanical failures such as breakage. |
| Root cause | Device Design |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated September 3, 2015, to all affected customers. The letter identified the product the problem and the action need to be taken by the customer. ACTIONS REQUIRED: We have record that your facility has received the product(s) subject to this recall. It is important to note that the 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 has developed a replacement & recovery plan for indicated devices and replacement p |
| Quantity | 1550 |
| Distribution | US (nationwide) distribution and one Internationally to Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.