Recall Z-0115-2008 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), Biomet Orthopedics, Inc., Warsaw, IN. 46581
| Date | Jan 23, 2008 (initiated Sep 4, 2007) |
| Status | Terminated |
| Reason | Binding: The instrument was manufactured incorrectly and its use may result in binding to the acetabular component and cause the implant to not release following impaction. |
| Root cause | Other |
| Action | Consignees were notified by Urgent Medical Device Correction Notice (letter) dated 9/4/07 to discontinue use of the instruments and to return them for evaluation. |
| Quantity | 22 |
| Distribution | Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.