Z-0282-2024 Class II Ongoing
FDA device recall Z-0282-2024 was initiated by Encore Medical, LP on Sep 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
- Nov 15, 2023
- Initiation Date
- Sep 25, 2023
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0282-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026