FDAClass IIJune 9, 2021

10 Gauge Direct Unilateral Stylet(1 X Diamond 1 X recall

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

Why was 10 Gauge Direct Unilateral Stylet(1 X Diamond 1 X recalled?

Products distributed as sterile may not have been adequately sterilized

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Batch: 19102741, 200127, 2001246

Product
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
Recalling firm
Zavation
Quantity
56 units
Distribution
US nationwide distribution.
Recall date
June 9, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls