Recall Z-0388-2014 ยท LXH Orthopedic Manual Surgical Instrument
Synthes USA HQ, Inc.
Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
| Date | Nov 25, 2013 (initiated Jul 31, 2013) |
| Status | Terminated |
| Reason | All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension. |
| Root cause | Device Design |
| Action | Synthes sent an Urgent: Medical Device Recall letter dated July 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. "Please remove this product from your inventory and return it to Synthes. A replacement product will be sent to you when available. If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicati |
| Quantity | 369 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.