—#85910

Product

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.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070389
Affected lot / code info: All lots. Lot Numbers: 006120, 006130, 006150, 310980, 457500, 457510, 457520, 528050, 549180, 597000, 597010, 689520, 689530, 689540, 843100, 843140, 933310 and 933320.

Why it was recalled

These anchors may be difficult to remove, or may not detach from the inserter shaft.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Worldwide Distribution -- United States and Belgium.

Timeline

Recall initiated: 2009-09-09
Posted by FDA: 2009-11-12
Terminated: 2011-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85910. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.