FDA Recall
Terminated
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.
Recall: Z-0191-2010
·
Initiated September 9, 2009
Recall
- Recall Number
- Z-0191-2010
- Event Number
- 53581
- Firm
- Biomet, Inc.
- FEI Number
- 1825034
- Product Code
- HWC
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- September 9, 2009
- Posted
- November 12, 2009
- Terminated
- January 19, 2011
- Address
- 56 E Bell Dr, Warsaw, IN, 46582
Description
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.
Reason
These anchors may be difficult to remove, or may not detach from the inserter shaft.
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.
Distribution
Worldwide Distribution -- United States and Belgium.
Quantity
894