Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904
FDA device recall Z-0191-2010 · posted 2009-11-12 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- These anchors may be difficult to remove, or may not detach from the inserter shaft.
- Action taken
- Biomet issued an "Urgent Medical Device Recall Notice" dated September 9, 2009 informing consignees of the affected product and requesting return of the device. Distributors were instructed to notify their customers copy of the recall letter and to locate and return the products from user facilities. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 894
- Distribution
- Worldwide Distribution -- United States and Belgium.
- Date initiated
- 2009-09-09
- Date posted
- 2009-11-12
- Date terminated
- 2011-01-19
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEEK KNOTLESS ANCHORS (K070389) | Biomet Sports Medicine, Inc. | 2007-08-09 |