Black Widow Plate 19mm Plate — Class II medical device recall Z-0886-2017
Terminated recall by Amendia, Inc, reported 2016-12-28, distributed nationwide. There is a problem with the mating feature between the plate and screw which could cause the plate opening not
| Recall number | Z-0886-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2016-11-22 |
| Classified | 2016-12-22 |
| Reported by FDA | 2016-12-28 |
| Terminated | 2017-07-31 |
| Distributed | Nationwide (US) |
| Quantity | 48 units |
| Lot numbers | 01838, 09286, NM01839, WT040813A, WT041213A, WT042213C, WT080112A, WT081712E, WT103014B, WT110714A, WT111213A, WT112113A, WT112210B, WT112210C, WT1127, WT112713, WT112713B |
| Model numbers | TB123, TBP119, TBP123 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0886-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.