Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6m
FDA device recall Z-0887-2017 · posted 2016-12-22 · Terminated
Recall details
- Recalling firm
- Amendia, Inc
- Reason for recall
- There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
- Action taken
- Amendia sent an Urgent Medical Device Recall letter dated November 22, 2016, to all affected consignees.. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. Customers with questions should call 1-855-755-3329. For questions regarding this recall call 404-610-7215.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 96 units
- Distribution
- Nationwide Distribution to IN, LA, and TX
- Date initiated
- 2016-11-22
- Date posted
- 2016-12-22
- Date terminated
- 2017-07-31
- Location
- Marietta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLACK WIDOW ANTERIOR BUTTRESS PLATE (K081770) | Omni Surgical, L.P. | 2009-04-02 |