FDAClass IIJuly 18, 2018

Femoral Nail recall

Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S

Why was Femoral 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: 04546540200693; Lot code: K08327F

Product
Femoral Nail, A/R, R1500 T2 Femur ¿12x380 mm, Product Number 18281238S
Recalling firm
Stryker GmbH
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