I.T.S. proximal humeral plates heat more in MRI than stated
I.T.S. GmbH is recalling the Humeral Head Plate with Angular Stability because updated MRI safety testing shows higher RF-induced temperature increases than the Instructions for Use previously reflected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: implanted hardware may heat more during MRI than its instructions state, and no injuries are stated in the source.
Plain-English summary
I.T.S. GmbH is recalling the Humeral Head Plate with Angular Stability, a proximal humeral plate, across thirteen article numbers. About 292 units were distributed across 30 US states and territories. The FDA has classified this recall as Class II.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use.
Affected product is listed by article number and lot number in the FDA enforcement record.
Facilities can identify affected implants by the article and lot numbers, and may contact I.T.S. GmbH for further information.
The recalled product
- Product
- Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate. Article Numbers: 211341-10, 211341-4, 211341-7, 21134-4, 21134-5, 21135-4, 21136-4, 21136-5, 21136-7, 21137-4, 21137-7, 21138-4, 21139-4.
- Manufacturer
- I.T.S. GmbH
- Hazard
- mri-heating
- rf-induced-heating
- instructions-understated
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Article Number (Lot Numbers): 211341-10 (26/F63368
- 26/F65625
- 26/F66904
- 26/F669041
- 679/012410)
- 211341-4 (26/F63366
- 26/F65626
- 26/F656261
- 26/F66145
- 26/F661451
- 26/F66496
- 26/F66905
- 26/F669051
- 26/F73497
- 679/012439
- 679/022450)
- 211341-7 (26/F63367
- 26/F65627
- 26/F66146
- 26/F66906
Distribution
Distributed nationwide across the United States.
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