medical MODERATE Updated 2026-04-01

I.T.S. GmbH recalls HLS - Hand Locking Plates System with the below descriptions

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Recalled Product

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.

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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).

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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