CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

Black Widow Plate Plate recalled by Amendia

Amendia is recalling Black Widow Plate Plate, distributed nationwide in the US. The recall was initiated on 22 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled48 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0886-2017
FDA event ID: 75869
Recalling firm: Amendia, Marietta, GA
Classification: Class II
Status: Terminated
Recall initiated: 22 Nov 2016
FDA classified: 22 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

22 Nov 2016	Recall initiated by company
22 Dec 2016	Classified by FDA	+30 days
28 Dec 2016	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution to IN, LA, and TX

Nationwide Indiana Louisiana Texas

Questions about this recall

Is Black Widow Plate Plate recalled?

Yes. Amendia recalled Black Widow Plate Plate on 22 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0886-2017.

Why was it recalled?

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.

Which lots are affected?

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

Where was it sold?

Nationwide Distribution to IN, LA, and TX

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Amendia

All 12

Reported	Class	Recall	Company	Reason	Where
17 Jan 2018Device	CLASS II	Mac Pin Non-Cannulated Screw recalled by Amendia	Amendia	Labeling Errors	GA
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20 Dec 2017Device	CLASS II	Piranha Screw 0, used in Piranha Surgical Plate System recalled	Amendia	Other	9 states
3 May 2017Device	CLASS II	K-Wire, Threaded Blunt recalled by Amendia	Amendia	Labeling Errors	GA, KS, TX
18 Jan 2017Device	CLASS II	Ceres-C Standalone Cervical Interbody The product is recalled by Amendia	Amendia	Other	GA

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