Stryker Corporation recalls STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.

Recall date

November 17, 2017

Source

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

Recall number

Z-0837-2018

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.

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 WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model 0234010056, labeled sterile.