Amendia Recalls Black Widow Spinal Plates Due to Mating Feature Defect
Amendia, Inc. is recalling 48 units of Black Widow Buttress Plates due to a design defect in the mating feature between the plate and screw.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a mechanical defect in a spinal implant that could compromise device function, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Amendia, Inc. is recalling 48 units of Black Widow Buttress Plates, specifically the 19mm Plate (Part Number TBP119) and 23mm Plate (Part Number TBP123). These medical devices are designed to prevent the migration or expulsion of allograft or autograft in the thoracolumbar to S1 spinal region. The recall covers specific lot numbers for both part numbers, including WT103014B, WT112210B, and NM01839.
The recall was initiated because of a problem with the mating feature between the plate and the screw. This defect could cause the plate opening not to interfere enough with the plate and the head of the screw. The affected units were distributed nationwide to Indiana, Louisiana, and Texas.
Healthcare providers and facilities that have received these products should stop using them and contact Amendia, Inc. for instructions on how to return the devices. Patients who have had these implants should consult their healthcare provider to discuss the potential implications of this defect.
The recalled product
- 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
- Manufacturer
- Amendia, Inc
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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
Part of a larger recall action
This product is one of 2 recalled by Amendia, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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