—#98992

Product

Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

FDA product code: HWD — Starter, Bone Screw
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K991807
Affected lot / code info: Part: 103532, Lot: 427460; and Part: 103533, Lot: 502360.

Why it was recalled

One lot of 30 mm screws was switched with one lot of 25 mm screws.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Biomet Orthopedics sent an Urgent Medical Device Recall Notice letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove the affected lots from their inventory, and return them to Biomet. Complete and enclosed FAX Back Response Form to 574-372-1683 prior to return of product. Distributors were instructed to notify all sub-accounts of the recall. Confirm receipt of notice by calling, 800-348-9500, extension 3755 or 3983. For questions regarding this recall call 574-372-3983, Monday through Friday, 8AM to 5PM.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including CA, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, ND, NJ, NY, OK, PA, SD, TX, VA, WA, and WI and the country of Japan.

Timeline

Recall initiated: 2011-03-10
Posted by FDA: 2011-05-03
Terminated: 2012-02-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #98992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.