Reported Apr 1, 2026 · Ongoing
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical…
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?
- Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking
- Article Numbers
37351-10-N37351-12-N37351-14-N37351-16-N37351-18-N37351-20-N37351-22-N37351-24-N37351-26-N37351-28-N37351-30-N37351-32-N37351-34-N37351-36-N37351-38-N37351-40-N37351-42-N37351-44-N37351-46-N37351-48-N37351-50-N37351-55-N37351-60-N37351-65-N37351-70-N37351-75-N37351-80-N37351-85-N. 2. Humeral PlateDistal
- Article Numbers
21241-521241-721242-721243-1021244-9
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
132 of 132 codes
37351-10-N (18/240314679/122205)37351-12-N (18/20033018/94397726/F65544679/032401679/052417679/122261)37351-14-N (18/20133118/51150418/94497826/F65545679/032402679/032514679/052244679/052418679/052516679/072520)37351-16-N (18/20233218/52150518/94597926/F65163679/032423679/032504679/052201679/062466679/062504679/072521679/122251)37351-18-N (18/20333318/53150618/94698018/97121526/F65546679/022329679/022516679/032430679/062206679/062505679/072522)37351-20-N (18/23133418/54150718/95298126/F6516426/F65547679/032431679/062230679/072501679/122202)37351-22-N (18/23333518/95398226/F65548679/062233679/092111679/122210)37351-24-N (18/23833618/95698326/F65549679/042415679/072203
- Article Number (Lot Numbers)
21241-5 (770/201905)21241-7 (770/201906)21242-7 (770/201901)21243-10 (770/201901)21244-9 (770/201905)
- Amount recalled
- 12,059 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.
Free recall alerts
Get alerted about new I.T.S. GmbH recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.