FDAClass IIJuly 18, 2018

Tibial Nail recall

Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S

Why was Tibial Nail recalled?

The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

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?

GTIN 04546540197771; Lot code: K074846

Product
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Recalling firm
Stryker GmbH
Quantity
12
Distribution
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Recall date
July 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls