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U.S. Department of Health and Human Services

Class 3 Device Recall Ascension Modular Radial Head (MRH) Radial Head Implant

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  Class 3 Device Recall Ascension Modular Radial Head (MRH) Radial Head Implant see related information
Date Initiated by Firm November 16, 2018
Create Date February 02, 2019
Recall Status1 Terminated 3 on November 22, 2019
Recall Number Z-0794-2019
Recall Event ID 81782
510(K)Number K062861  
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
Product Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
Code Information 170691
Recalling Firm/
Manufacturer		 Ascension Orthopedics, Inc
8700 Cameron Rd Ste 100
Austin TX 78754-3947
For Additional Information Contact Dr. Patricai Kihn
609-750-4220
Manufacturer Reason
for Recall		 The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
FDA Determined
Cause 2		 Vendor change control
Action On 11/16/18, the recalling firm sent out an Urgent Voluntary Medical Device Correction letter via email to affected customers to notify them of the product issue. A second, updated letter was sent on 12/13/18. The firm requests that all recipients please examine their inventory to determine if they have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691. Customers: - If you do have any MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please discard the First Choice DRUJ System Partial Ulnar Head Implant instructions packaged with the product and use the attached correct IFU provided to you along with this communication letter. Distributors: - If you do have any unused MRH Radial Head Implants, catalog number, MRH-350-04-WW, from lot number, 170691 please return them to Integra. - We also kindly ask you to provide us the final customer list who may have the affected products. Integra will provide them the correct IFU. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM  8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com Outside USA: 1- 609-936-5400; email: INTERNATIONALCS@integralife.com
Distribution Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
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 = HSD and Original Applicant = ASCENSION ORTHOPEDICS, INC.
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