Recall Z-0384-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
| Date | Nov 22, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required. |
| Root cause | Labeling design |
| Action | The firm, Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated July 31, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove the affected lots from stock; If you do have the affected devices, contact Synthes at 1-800-479-6329 to obtain the RA# and return the product to with completed form to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; complete and sign the Return Receipt Requested form via fax at 1-888-731-7955 or email to: FieldAction@synth |
| Quantity | 634 |
| Distribution | Worldwide distribution: US (nationwide) and countries of Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.