Z-1526-2018Class II

Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures...

Name: Z-1526-2018 Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures...
Creator: Stryker GmbH
Published: 2018-03-12
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-03-12 / Terminated / root cause: labeling and UDI

FDA source

Stryker GmbH began a recall of Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone... on 2018-03-12. FDA classified it as Class II and gives the reason as "The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1526-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-12
Posted: 2018-04-26
Terminated: 2020-05-21
Recalling firm: Stryker Corp.
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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Stryker sent an Urgent Product Recall letter dated March 12, 2018, to all affected customers. . Product will be returned to the manufacturer for disposition. Non-responding consignees will be attempted to be contacted a minimum of three times in total. Returned product will be quarantined and returned to the manufacturer. Product will be returned to the manufacturer for disposition. For further questions, please call (201) 831-5272.
Quantity in commerce: 18
Distribution: USA (nationwide) Distribution
Product codes and lots: Lot # L23745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1526-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1526-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-26

Product code KTT

K113327Class IIHoffmann Lrf (Limb Reconstruction Frame) SystemStryker Corp. / cleared 2012-03-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)