Biomet Straight Magnum Inserter Handle, a preparatory instrument used for acetabular component insertion; REF # or Catal
FDA device recall Z-1151-2007 · posted 2007-08-07 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 94
- Distribution
- World wide: USA, Australia, and Finland.
- Date initiated
- 2007-06-14
- Date posted
- 2007-08-07
- Date terminated
- 2007-12-12
- Location
- Warsaw, IN
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