FDA Device recall Z-0886-2017
Black Widow Plate 19mm Plate, Part Number TBP119
- FDA Device
- Class II
- terminated
- Published 2016-12-28
On 2016-12-28 the FDA classified a Class II recall of Black Widow Plate 19mm Plate, Part Number TBP119 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-0886-2017 |
| 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 Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 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 TBP119 Lot Number WT103014B, WT112210B, 01838, WT111213A, WT040813A, WT042213C; Part Number TB123 Lot N…Part Number TBP119 Lot Number WT103014B, WT112210B, 01838, WT111213A, WT040813A, WT042213C; Part Number TB123 Lot Number NM01839, WT080112A, WT081712E, WT112210C, WT112113A, WT112713B, WT110714A, WT1127, 09286, WT041213A, WT112713 |
|---|
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-0886-2017%22
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