HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.

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): 32151-6 (18/408462, 18/500495, 18/691266), 32151-8 (18/408866, 18/531370), 32151-9 (18/351668, 18/541373, 18/741269), 32151-10 (18/408986, 18/551374), 32151-11 (18/371670, 18/561375), 32151-12 (18/409087, 18/571376, 18/771272), 32151-13 (18/581377), 32151-14 (18/409289, 18/591378, 18/791274), 32151-15 (18/409390), 32151-16 (18/409491), 32151-18 (18/821277), 32151-20 (18/831278). 2. Article Number (Lot Numbers): 21505-4 (86/350493, 86/677353), 21506-4 (86/642718, 86/677157). 3. Article Number (Lot Numbers): 21507-4 (26/F65050), 21508-4 (26/F63934, 86/677180). 4. Article Number (Lot Numbers): 21517 (26/F66911). 5. Article Number (Lot Numbers): 21502 (86/677136), 21503-4 (86/337934), 21503-6 (86/868870), 21503-8 (26/F63936), 21503-10 (86/337896, 86/677146), 21504-6 (26/F63364, 86/868885), 21504-8 (26/F63365), 21504-10 (86/642711, 86/677154). 6. Article Number (Lot Numbers): 21513-3 (86/677385), 21513-5 (86/677389), 21514-3 (26/F63935), 21514-5 (86/642722, 86/677183, 86/869183). 7. Article Number (Lot Numbers): 37151-5 (18/561228), 37151-8 (18/166019), 37151-9 (18/625633), 37151-10 (18/626634), 37151-12 (18/628636, 18/671232), 37151-13 (18/166423), 37151-15 (18/206189), 37151-16 (18/132035, 18/691234), 37151-18 (18/142036), 37151-24 (18/167068, 18/172039), 37251-8 (18/421197), 37251-9 (18/591223), 37251-11 (18/619644), 37251-12 (18/620645, 18/962052), 37251-13 (18/521703), 37251-14 (18/531704, 18/951141), 37251-16 (18/002056, 18/031952, 18/623648, 18/971143), 37251-20 (18/571708, 26/F61731).

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.