FDA Device recall Z-0887-2017
Black Widow 6.6mm x 20mm Screw, Part Number TBS020
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Black Widow 6.6mm x 20mm Screw, Part Number TBS020 by Amendia, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0887-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-22 |
| Published | 2016-12-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amendia |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Part Number TBS020 Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836…Part Number TBS020 Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836R; Part Number TBS025 Lot Number 09161, 09286R, WT090314B, WT112613B, 08218, 08337, 09287R, NM01837, 08216; Part Number TBS030 Lot Number 08218, WT011711B, WT071014A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0887-2017%22
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