FDA-Device2018-05-02Class II

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.

Stryker GmbH
Hazard

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

Sold states
USA (nationwide) Distribution
Affected count
18
Manufactured in
Bohnackerweg 1, N/A, Selzach, N/A, Switzerland
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1526-2018

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