FDAClass IIJune 18, 2025

Long Nail recall

Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.

Why was Long Nail recalled?

Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.

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?

Catalog Number: 84250320S. GTIN: 07613327479515. Lot Number: K1BC9B7.

Product
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Recalling firm
Stryker GmbH
Distribution
Worldwide - US Nationwide distribution in the states of AL, FL, NJ, OR and the countries of Australia and Japan.
Recall date
June 18, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls