FDA Recall Terminated

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.

Recall: Z-1526-2018 · Initiated March 12, 2018

Recall

Recall Number
Z-1526-2018
Event Number
79751
Firm
Stryker GmbH Bohnackerweg 1 Selzach Switzerland
FEI Number
3002807830
Product Code
KTT
Status
Terminated
Root Cause
Labeling mix-ups
Initiated
March 12, 2018
Terminated
May 21, 2020

Description

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.

Reason

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

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.

Distribution

USA (nationwide) Distribution

Quantity

18