FDAClass IIFebruary 8, 2023

OSS Modular Arthrodesis Nail recall

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including…

Why was OSS Modular Arthrodesis Nail recalled?

Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620

Product
OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including…
Recalling firm
Biomet, Inc.
Quantity
2 units
Distribution
US Nationwide distribution in the states of CA, KY, FL.
Recall date
February 8, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls