Z-0886-2017 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
- 48 units
Product Description
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.
Distribution Pattern
Nationwide Distribution to IN, LA, and TX
Code Information
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