Recall Z-0098-2024 ยท PHX Shoulder Prosthesis, Reverse Configuration
Encore Medical, LP
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
| Date | Oct 12, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| Reason | Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation. |
| Root cause | Mixed-up of materials/components |
| Action | On 8/22/23, recall notices were emailed to agents and registration holders who were asked to do the following: Contact Customer Service at 1-800-456-8696 to assist with return and replacement. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. Complete and return the acknowledgement and response form. If you have questions, please email productsafety@enovis.com |
| Quantity | 70 |
| Distribution | US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041066 | ENCORE REVERSE SHOULDER PROSTHESIS Encore Medical L.P., Mar 24, 2005 |