Recall Z-1151-2007 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catalog Number: S313141. (systems affected by this action include M2a-Magnum, Regenerex, Acetabular Revision Shell and M2a-38)
| Date | Aug 7, 2007 (initiated Jun 14, 2007) |
| Status | Terminated |
| Reason | The instrument was manufactured incorrectly and use could result in the instrument binding to the acetabular component and cause implant to not release following inpaction. |
| Root cause | Other |
| Action | On 6/13/07, the firm sent a Urgent Medica Device Correction Notice to its sales force instructing them to retrieve affected units from their hospital accounts and to return them to the firm. International accounts were notified via email on 6/14/07. |
| Quantity | 94 |
| Distribution | World wide: USA, Australia, and Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.