Recall Z-2504-2010 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Modular Microplasty Cup inserter 3/8" thread , REF 31-400600
| Date | Sep 25, 2010 (initiated Jul 28, 2010) |
| Status | Terminated |
| Reason | There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of "music wire" The recalling frim conducted tests to determine the effects of theis change in materials. The testing showed that the wire would oxidize and there would be early failure of the device. |
| Root cause | Employee error |
| Action | The firm send URGENT MEDICAL DEVICE RECALL NOTICES to its distributors on 7/28/2010. The notices instructed the distributors to discontinue use of the product and return it to Biomet. |
| Quantity | 331 total for both products |
| Distribution | US, Australia, Canada, Mexico, Chile, Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.