FDAClass IIAugust 11, 2021

Nail Insertion Sleeve recall

Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S

Why was Nail Insertion Sleeve recalled?

The devices have a different inner diameter than the diameter specified on the outer box label.

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?

GTIN 04546540715357, Lot Number K03CC4F

Product
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), Catalog Number 18061406S
Recalling firm
Stryker GmbH
Quantity
242
Distribution
US Nationwide Distribution
Recall date
August 11, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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