Recall Z-0266-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker Howmedica Osteonics Corp.
Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone
| Date | Nov 8, 2012 (initiated Jul 3, 2012) |
| Status | Terminated |
| Reason | Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS. |
| Root cause | Device Design |
| Action | Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated July 2, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Business Reply Form was included for customers to complete and return to via fax to 1-865-252-3635. Contact the firm at 1-866-626-7747 for assistance. |
| Quantity | 165 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113327 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Corp., Mar 29, 2012 |