Z-1593-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2026
- Initiation Date
- January 23, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 322 units
Product Description
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Reason for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.
Code Information
1. Article Number (Lot Numbers): 21116-8 (679/092230), 21117-10 (679/032313, 679/092231), 21118-10 (679/032314, 679/072047, 679/092232). 2. Article Number (Lot Numbers): 21121-6 (679/092236, 679/092329), 21121-8 (679/052226). 3. Article Number (Lot Numbers): 21122-10 (00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Article Number (Lot Numbers): 21123-4 (00/0810-06, 679/052014, 679/062216), 21124-4 (679/042333, 679/062217, 679/072346), 21127-6 (679/052228), 21128-6 (679/042341).