FDA-Device2018-07-18Class II
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
Stryker GmbH
Hazard
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.
Sold states
The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.
Affected count
7
Manufactured in
Bohnackerweg 1, Selzach, Switzerland
Products
Femoral Nail, A/R, R1500 T2 Femur ¿10x320 mm, Product Number 18281032S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2398-2018Don't want to check this manually?
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