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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 24, 2017
Create Date August 08, 2018
Recall Status1 Open3, Classified
Recall Number Z-2670-2018
Recall Event ID 79315
510(K)Number K062898  
Product Classification Prosthesis, Elbow, Hemi-, Radial, Polymer - Product Code KWI
Product Lat Assembly, Rad Stem Implant,Collar 6mm,Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Code Information 310-0007
Recalling Firm/
Manufacturer
Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact
201-831-5000
Manufacturer Reason
for Recall
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
FDA Determined
Cause 2
Under Investigation by firm
Action On October 27, 2017 an URGENT MEDICAL RECALL NOTIFICATION was issued to customers titled Product Field Action PR 1642784. The letter requests that recipients notify all necessary individuals within their organization of the recall and that a Stryker trauma representative will collect any affected product from the customer location. Questions or concerns can be directed to 201-831-6693
Quantity in Commerce 175
Distribution Distribution US Nationwide.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KWI and Original Applicant = SMALL BONE INNOVATIONS INC.
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