Recall Z-0887-2017 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Amendia, Inc
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
| Date | Dec 22, 2016 (initiated Nov 22, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 96 units |
| Distribution | Nationwide Distribution to IN, LA, and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081770 | BLACK WIDOW ANTERIOR BUTTRESS PLATE Omni Surgical, L.P., Apr 2, 2009 |