Stryker Corporation recalls ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

Recall date

November 17, 2017

Source

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

Recall number

Z-0838-2018

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

Distributed domestically to . Distributed internationally to Australia and Mexico.

Why it was recalled

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

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

What was recalled

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.