FDA-Device2020-06-24Class II
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Stryker GmbH
Hazard
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
Affected count
OUS: 1404
Manufactured in
Bohnackerweg 1, Selzach, Switzerland
Products
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2382-2020Don't want to check this manually?
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