Device 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
Z-0886-2017
Product summary
- Firm
- Amendia, Inc
- Event
- Event 75869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-0886-2017
Official wording
Reason: 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.
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
Distribution pattern: Nationwide Distribution to IN, LA, and TX
Derived failure modes
-
Unknown
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.