Low Profile Screw recall
Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to…
Why was Low Profile Screw recalled?
Screws provided in the device package are 6 mm longer than intended.
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 Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
- Product
- Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to…
- Recalling firm
- Arthrex, Inc.
- Quantity
- 20 units
- Distribution
- US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)