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Recall Observatory FDA recall evidence

Device product

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.

Z-1526-2018

March 12, 2018

Class II

Product summary

Firm
Stryker GmbH
Event
Event 79751
Status
Terminated
Classification
Class II
Quantity
18
Official record key
device-enforcement:Z-1526-2018

Official wording

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

Code information: Lot # L23745

Distribution pattern: USA (nationwide) Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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