FDA Device

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.

Hazard

Products distributed as sterile may not have been adequately sterilized

What You Should Do

Remedy

Zavation initially notified their consignees of the problem by email beginning on 03/24/2021 and requested they quarantine the product. The firm sent a subsequent email beginning on 04/13/2021 requesting the return of the product. The recall is being conducted to the user level.

Products

10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Brand
Zavation
UPC
Product Batch: 19102741, 200127, 2001246

Units Affected

56 units