PlainRecalls
FDA Devices Moderate Class II Terminated

Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

Reported: July 18, 2018 Initiated: April 27, 2018 #Z-2398-2018

Product Description

Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S

Reason for Recall

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.

Details

Recalling Firm
Stryker GmbH
Units Affected
7
Distribution
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Location
Selzach

Frequently Asked Questions

What product was recalled?
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S. Recalled by Stryker GmbH. Units affected: 7.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 18, 2018. Severity: Moderate. Recall number: Z-2398-2018.