Encore Medical, LP Recall 93080
Description: REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Encore Medical, LP Recall 93080 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0098-2024 |
| Event ID | 93080 |
| Event Description | REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130 |
| Product Type | Devices |
| Distribution | US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX |
| Quantity | 70 |
| Recall 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. |
| Device Classification | 20231018 |
| Device Code Info | UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9 |
| Center Classification Date | 20231012 |
| Recall Initiation Date | 20230822 |
| Recalling Firm | Encore Medical, LP |
| Initial Notification | Letter |
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