Recall Z-0191-2010 ยท HWC Screw, Fixation, Bone
Biomet, Inc.
Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P. Intended to be implanted for fixation of bone fractures and for bone reconstructions.
| Date | Nov 12, 2009 (initiated Sep 9, 2009) |
| Status | Terminated |
| Reason | These anchors may be difficult to remove, or may not detach from the inserter shaft. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 894 |
| Distribution | Worldwide Distribution -- United States and Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070389 | PEEK KNOTLESS ANCHORS Biomet Sports Medicine, Inc., Aug 9, 2007 |