TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM Biomet Sports Medicine manufactures a variety of internal fixation devic
FDA device recall Z-0753-2013 · posted 2013-01-30 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Thru hole at the tip of the screw is undersized.
- Action taken
- Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated January 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed locate and discontinue use of the affected product and return it to Biomet. recall notification was sent to all consignees on 1/4/2013. The action requires the immediate location and discontinued use of the product and its return to Biomet. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 44 units distributed
- Distribution
- Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY, TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
- Date initiated
- 2013-01-03
- Date posted
- 2013-01-30
- Date terminated
- 2013-08-02
- 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 |
|---|---|---|
| ARTHROTEK INTERFERENCE SCREW (K934469) | Biomet, Inc. | 1994-02-23 |