Recall Z-1186-2008 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet brand Modular Microplasty Cup Impactor, 3/8" - 24 Thread Insert; Model 31-400603. Instrument for hip prosthesis acetabular cup component.
| Date | Aug 20, 2008 (initiated Jan 16, 2008) |
| Status | Terminated |
| Reason | The weld at the lock location may fracture during impaction. |
| Root cause | Device Design |
| Action | Biomet notified distributors and medical facilities by letter dated 1/16/08. Distributors with distributor-owned instruments at medical facilities were notified by email on 1/17/08, and provided with a letter to present to their associated medical facilities describing the recall. |
| Quantity | 59 |
| Distribution | Worldwide Distribution: USA, Germany, Mexico, Netherlands, Sweden and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.