Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catal
FDA device recall Z-0115-2008 · posted 2008-01-23 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 22
- Distribution
- Nationwide; including states of Alabama, Arizona, Arkansas, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Nevada, North Carolina, Ohio and South Dakota.
- Date initiated
- 2007-09-04
- Date posted
- 2008-01-23
- Date terminated
- 2009-09-22
- Location
- Warsaw, IN
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