Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsa
FDA device recall Z-2135-2011 · posted 2011-05-03 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- One lot of 30 mm screws was switched with one lot of 25 mm screws.
- Action taken
- 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.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- HWD
- Quantity affected
- 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.
- Date initiated
- 2011-03-10
- Date posted
- 2011-05-03
- Date terminated
- 2012-02-17
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TITANIUM LOW PROFILE SCREWS (K991807) | Biomet, Inc. | 1999-07-08 |