Recall Z-0794-2019 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Ascension Orthopedics, Inc
Ascension Modular Radial Head (MRH) Radial Head Implant, Catalog Number, MRH-350-04-WW
| Date | Nov 16, 2018 |
| Status | Terminated |
| Reason | The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). |
| Root cause | 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 |
| Distribution | Distributed to accounts in MO. Foreign distribution to Korea and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062861 | ASCENSION HUMERAL RESURFACING ARTHROPLASTY SYSTEM Ascension Orthopedics, Inc., Oct 31, 2006 |