Reported Dec 28, 2016 · Terminated
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow…
Amendia, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Amendia, Inc · 1755 W Oak Pkwy · Marietta, GA · 30062-2260
Is this the product you have?
- 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
- Lot codes and dates
Part Number TBP119 Lot Number WT103014BWT112210B01838WT111213AWT040813AWT042213CPart Number TB123 Lot Number NM01839WT080112AWT081712EWT112210CWT112113AWT112713BWT110714AWT112709286WT041213AWT112713
- Amount recalled
- 48 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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