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U.S. Department of Health and Human Services

Class 2 Device Recall Hinge Coupling Hoffmann LRF

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  Class 2 Device Recall Hinge Coupling Hoffmann LRF see related information
Date Initiated by Firm March 12, 2018
Create Date April 26, 2018
Recall Status1 Terminated 3 on May 21, 2020
Recall Number Z-1526-2018
Recall Event ID 79751
510(K)Number K113327  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
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.
Code Information Lot # L23745
Recalling Firm/
Manufacturer
Stryker GmbH
Bohnackerweg 1
Selzach Switzerland
For Additional Information Contact Aminah Crawford
201-831-5272
Manufacturer Reason
for Recall
The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = STRYKER CORP.
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