RegWardenFDA facility compliance records
Recall

Class II — Stryker GmbH

Recalling firmSTRYKER CORP.
Registered facilityView this company's 61 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
ProductHinge 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.
Quantity18
DistributionUSA (nationwide) Distribution
Initiated2018-03-12
Classified2018-04-26
Terminated2020-05-21
Recall numberZ-1526-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Stryker GmbH (Z-1526-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79751/

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