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Stryker GmbH recalls Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are
Recalled June 24, 2020 · FDA recall Z-2382-2020 · Stryker
Hazard
Seal integrity of the blister pack may be compromised and sterility cannot be assured · FDA Class II
Units
OUS: 1404
Sold at
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.
Description
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Product
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.
Manufacturer(s)
Stryker GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →