Device product
RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Z-0282-2024
Product summary
- Event
- Event 93221
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-0282-2024
Official wording
Reason: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
Code information: UDI-DI: 00888912144667, Lot: 390P1157
Distribution pattern: US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Derived failure modes
-
Unknown
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.