Recall Z-1057-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes, Inc.
Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia system, LFN and RAFN systems. Their function is to insert a nail. The Synthes Driving Cap/Threaded is threaded into the insertion handle and secured with a wrench. If desired, the nail can then be inserted using light hammer blows.
| Date | Feb 20, 2014 (initiated Jan 7, 2014) |
| Status | Terminated |
| Reason | The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assembled becoming difficult to separate. |
| Root cause | Process design |
| Action | Synthes sent an Urgent Notice - Medical Device Recall Letter dated January 7 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Action to be taken: Our records indicate that your facility has the product(s) subject to this Recall. Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization Numb |
| Quantity | 143 |
| Distribution | USA (nationwide) Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.