Recall Z-2135-2011 ยท HWD Starter, Bone Screw
Biomet, Inc.
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.
| Date | May 3, 2011 (initiated Mar 10, 2011) |
| Status | Terminated |
| Reason | One lot of 30 mm screws was switched with one lot of 25 mm screws. |
| Root cause | Mixed-up of materials/components |
| Action | 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 reca |
| Quantity | 100 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991807 | TITANIUM LOW PROFILE SCREWS Biomet, Inc., Jul 8, 1999 |