Device product
REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Z-0098-2024
Product summary
- Event
- Event 93080
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70
- Official record key
device-enforcement:Z-0098-2024
Official wording
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.
Code information: UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9
Distribution pattern: US: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Derived failure modes
-
Unknown
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.