Z-1603-2026 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
- 176 units
Product Description
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1. DFL (Distal Femur Locking) Distal Femur Plate; Article Numbers: 21301-5, 21301-7, 21301-9, 21301-13, 21302-5, 21302-7, 21302-9, 21302-13. 2. PTL (Proximal Lateral Tibia Locking) Proximal Lateral Tibia Plate; Article Numbers: 21321-7, 21321-12, 21322-7, 21322-12. 3.PTL (Proximal Lateral Tibia Locking) Proximal Medial Tibia Plate; Article Numbers: 21325-4, 21325-7.
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): 21301-5 (26/F62569), 21301-7 (26/F62570), 21301-9 (26/F67518), 21301-13 (26/F62568, 26/F67815), 21302-5 (26/F67520), 21302-7 (26/F67821), 21302-9 (26/F62572, 26/F67822), 21302-13 (26/F62571, 26/F67519, 26/F67820). 2. Article Number (Lot Numbers): 21321-7 (26/F54955, 26/F62576), 21321-12 (26/F55883), 21322-7 (26/F55890, 26/F62578), 21322-12 (26/F62577). 3. Article Number (Lot Numbers): 21325-4 (26/F70528, 679/022433, 679/032217, 679/102240, 679/102242, 679/102303), 21325-7 (679/102241, 679/102304).