PlainRecalls
FDA Devices Moderate Class II Terminated

Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S

Reported: July 18, 2018 Initiated: April 27, 2018 #Z-2407-2018

Product Description

Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S

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
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?
Ankle Arthrodesis Nail, right T2 Ankle ¿10x300mm, Product Number 18191030S. Recalled by Stryker GmbH.
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-2407-2018.