Date Initiated by Firm | October 24, 2017 |
Create Date | August 08, 2018 |
Recall Status1 |
Terminated 3 on May 18, 2023 |
Recall Number | Z-2665-2018 |
Recall Event ID |
79315 |
510(K)Number | K062898 |
Product Classification |
Prosthesis, Elbow, Hemi-, Radial, Polymer - Product Code KWI
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Product | Lateral Assembly, Radial Stem Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system. |
Code Information |
310-0002 |
Recalling Firm/ Manufacturer |
Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
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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 | 492 |
Distribution | Distribution US Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = KWI
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