Reported Apr 1, 2026 · Ongoing
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw;…
I.T.S. GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: I.T.S. GmbH · Autal 28 · Lasnitzhohe · N/A
Is this the product you have?
- HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw
- Article Numbers
32151-632151-832151-932151-1032151-1132151-1232151-1332151-1432151-1532151-1632151-1832151-20. 2. HLS Plate2 T-Shape
- Article Numbers
21505-421506-4. 3. HLS Plate3 T-Shape
- Article Numbers
21507-421508-4. 4. HLS PlateSquare
- Article Numbers21517. 5. HLS Plate, Straight
- Article Numbers
2150221503-421503-621503-821503-1021504-621504-821504-10. 6. HLS PlateY-Shape
- Article Numbers
21513-321513-521514-321514-5. 7. Locking Stabilization Screw
- Article Numbers
37151-537151-837151-937151-1037151-1237151-1337151-1537151-1637151-1837151-2437251-837251-937251-1137251-1237251-1337251-1437251-1637251-20
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
32151-6 (18/40846218/50049518/691266)32151-8 (18/40886618/531370)32151-9 (18/35166818/54137318/741269)32151-10 (18/40898618/551374)32151-11 (18/37167018/561375)32151-12 (18/40908718/57137618/771272)32151-13 (18/581377)32151-14 (18/40928918/59137818/791274)32151-15 (18/409390)32151-16 (18/409491)32151-18 (18/821277)32151-20 (18/831278). 2
- Article Number (Lot Numbers)
21505-4 (86/35049386/677353)21506-4 (86/64271886/677157). 3
- Article Number (Lot Numbers)
21507-4 (26/F65050)21508-4 (26/F6393486/677180). 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 (86/33789686/677146)21504-6 (26/F6336486/868885)21504-8 (26/F63365)21504-10 (86/64271186/677154). 6
- Article Number (Lot Numbers)
21513-3 (86/677385)21513-5 (86/677389)21514-3 (26/F63935)21514-5 (86/64272286/67718386/869183). 7
- Article Number (Lot Numbers)
37151-5 (18/561228)37151-8 (18/166019)37151-9 (18/625633)37151-10 (18/626634)37151-12 (18/62863618/671232)37151-13 (18/166423)37151-15 (18/206189)37151-16 (18/13203518/691234)37151-18 (18/142036)37151-24 (18/16706818/172039)37251-8 (18/421197)37251-9 (18/591223)37251-11 (18/619644)37251-12 (18/62064518/962052)37251-13 (18/521703)37251-14 (18/53170418/951141)37251-16 (18/00205618/03195218/62364818/971143)37251-20 (18/57170826/F61731)
- Amount recalled
- 1,307 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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