I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.

Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

Code information: 1. Article Number (Lot Numbers): 21604-6 (643/052301, 643/0652, 643/092201), 21604-9 (643/032311, 643/062308, 643/062309, 643/112310, 643/122201). 2. Article Number (Lot Numbers): 21605-11 (643/072314, 643/102207), 21605-6 (643/0654, 643/072306, 643/072316, 643/072338, 643/102208, 643/102212, 643/102217, 643/112306, 643/122202), 21605-9 (643/0643, 643/0662, 643/072307, 643/072339, 643/112309, 643/122203). 3. Article Number (Lot Numbers): 21105-6 (86/876787), 21105-8 (86/876788). 4. Article Number (Lot Numbers): 21104-4 (679/052234, 679/082305, 86/036334), 21104-5 (679/0722101, 679/082306, 86/036335), 21104-6 (679/012307, 86/876760), 21104-7 (679/082307, 86/036336, 86/876781), 21104-8 (679/082308, 86/876783), 21104-9 (86/876904). 5. Article Number (Lot Numbers): 21101-5 (86/876637), 21101-6 (679/121605, 00/1105-12, 26/F41923, 86/876638, 86/903610), 21101-7 (770/201905, 00/0518-06, 679/042303, 86/876640), 21101-8 (86/876721, 679/062224), 21101-9 (679/122264, 86/876727), 21101-11 (86/876633), 21101-13 (86/876635). 6. Article Number (Lot Numbers): 21102-6 (770/201905). 7. Article Number (Lot Numbers): 21103-8 (679/092216), 21103-9 (679/062215, 86/876758), 21103-10 (679/092219, 86/876741), 21103-11 (679/062214), 21103-12 (86/876743), 21103-13 (679/022303, 86/876745).

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.