Z-0282-2024 Class II Ongoing
FDA device recall Z-0282-2024 was initiated by Encore Medical, LP on September 25, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 20.
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 Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, 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: 00888912144667, Lot: 390P1157