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Terminated

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

FDA Recall Z-0887-2017 · Posted 2016-12-22

Recalling FirmAmendia, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2016-11-22
Date Terminated2017-07-31
Product Quantity96 units

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.

Firm 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.

Root Cause

Process change control

Distribution Pattern

Nationwide Distribution to IN, LA, and TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081770BLACK WIDOW ANTERIOR BUTTRESS PLATEOmni Surgical, L.P. · 2009-04-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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