Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
- Company
- Ascension Orthopedics, Inc
- Recall Initiated
- November 16, 2018
- Terminated
- November 22, 2019
- Recall Number
- Z-0794-2019
- Firm Location
- Austin, TX
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).
Distribution
Distributed to accounts in MO. Foreign distribution to Korea and Thailand.
Lot / Code Info
170691
Root Cause
Vendor change control
Action Taken
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