Recall Z-1318-2008 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter, Part number: 31-555610.
| Date | Sep 11, 2008 (initiated Feb 12, 2008) |
| Status | Terminated |
| Reason | The instrument will not mate with its stem. |
| Root cause | Process control |
| Action | Biomet distributors were notified via recall letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. |
| Quantity | 78 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.