Device product
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Z-0281-2024
Product summary
- Event
- Event 93221
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-0281-2024
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: 00190446257585, Lot: 954W1194
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.