Z-0887-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2016
- Initiation Date
- November 22, 2016
- Termination Date
- July 31, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 units
Product Description
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
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.
Distribution Pattern
Nationwide Distribution to IN, LA, and TX
Code Information
Part Number TBS020 Lot Number 0825R, NM01836, WT090314A, 09281, 09282, 09285, WT040412A, 08344, 09154, 09281R, NM01836R; Part Number TBS025 Lot Number 09161, 09286R, WT090314B, WT112613B, 08218, 08337, 09287R, NM01837, 08216; Part Number TBS030 Lot Number 08218, WT011711B, WT071014A