U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The wrong parts were picked for packaging. the connecting nuts were packed in the packaging labeled with hinge coupling.
조치
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.
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.