Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1.
FDA device recall Z-3289-2011 · posted 2011-09-30 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 6 units (internationally)
- Distribution
- International Distribution Only: Canada, Australia, and Columbia.
- Date initiated
- 2011-08-03
- Date posted
- 2011-09-30
- Date terminated
- 2011-10-26
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPREHENSIVE HUMERAL FRACTURE SYSTEM (K023063) | Biomet Orthopedics, Inc. | 2002-12-13 |