FDAClass IIAugust 5, 2020

Sterile Low Profile Screw recall

Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in…

Why was Sterile Low Profile Screw recalled?

Screws provided in packaging are 5mm shorter 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?

Batch Number: 10706233 UDI Number:00888867056411

Product
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in…
Recalling firm
Arthrex, Inc.
Quantity
28 units
Distribution
International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Recall date
August 5, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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