Z-0886-2017Class II

Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black...

Name: Z-0886-2017 Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black...
Creator: Amendia, Inc
Published: 2016-11-22
License: https://open.fda.gov/license/

Spinal Elements, Inc / initiated 2016-11-22 / Terminated

FDA source

Amendia, Inc began a recall of 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... on 2016-11-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0886-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2016-12-22
Terminated: 2017-07-31
Recalling firm: Spinal Elements, Inc
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
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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.
FDA 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 in commerce: 48 units
Distribution: Nationwide Distribution to IN, LA, and TX
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0886-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0886-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22
Z-0887-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code KWQ

K081770Class IIBlack Widow Anterior Buttress PlateOmni Surgical, L.P. / cleared 2009-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)