Z-0281-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 25, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Reason for Recall
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.
Distribution Pattern
US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Code Information
UDI-DI: 00190446257585, Lot: 954W1194