Stryker GmbH recalls Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are singl…

Recall date

May 7, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2373-2020

FDA classification

Class II

Brand / firm

Stryker GmbH

Sold / distributed

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.

Why it was recalled

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.