Stryker GmbH recalls Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb…

Recall date

March 12, 2018

Source

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

Recall number

Z-1526-2018

FDA classification

Class II

Brand / firm

Stryker GmbH

Sold / distributed

USA (nationwide) Distribution

Why it was recalled

The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

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

What was recalled

Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.