FDA Enforcement
Class II
Ongoing
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
Recall: Z-0281-2024
·
Reported November 15, 2023
Enforcement
- Recall Number
- Z-0281-2024
- Event ID
- 93221
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Encore Medical, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 15, 2023
- Initiation Date
- September 25, 2023
- Classification Date
- November 8, 2023
- Address
- 9800 Metric Blvd, Austin, TX, 78758-5445, United States
Description
RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
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 Info
UDI-DI: 00190446257585, Lot: 954W1194
Distribution
US: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CA
Quantity
20