Recall Z-3289-2011 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.
| Date | Sep 30, 2011 (initiated Aug 3, 2011) |
| Status | Terminated |
| Reason | Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed. |
| Root cause | Nonconforming Material/Component |
| Action | On 8/3/11 Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to locate the affected products, discontinue use, return the devices, and a fax a copy of the response form. For information or questions on this recall call Biomet at (574) 372-1570. |
| Quantity | 6 units (internationally) |
| Distribution | International Distribution Only: Canada, Australia, and Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM Biomet Orthopedics, Inc., Dec 13, 2002 |