Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavi
Summary
The FDA issued a Class II for Claviculaplate with Angular Stability, with the below descriptions and associate by I.T.S. GmbH. Reason: Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instruct.
Details
Source
Device Recall
External ID
Z-1593-2026
Action Date
2026-04-01
Status
Ongoing
Category
device
Product Description
Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1. Anterior Clavicle Plate, Medial; Article Numbers: 21116-8, 21117-10, 21118-10. 2. Clavicle Plate; Article Numbers: 21121-6, 21121-8. 3. Clavicle Plate, 3.5mm; Article Numbers: 21122-10, 21122-6, 21122-8. 4. Clavicle Plate, Lateral; Article Numbers: 21123-4, 21124-4, 21127-6, 21128-6.
Lot/Code Info: 1. Article Number (Lot Numbers): 21116-8 (679/092230), 21117-10 (679/032313, 679/092231), 21118-10 (679/032314, 679/072047, 679/092232). 2. Article Number (Lot Numbers): 21121-6 (679/092236, 679/092329), 21121-8 (679/052226). 3. Article Number (Lot Numbers): 21122-10 (00/0425-02, 00/0825-02, 679/022443, 679/062310, 86/043372), 21122-6 (00/0325-01, 00/0425-01, 679/042340, 679/062334, 679/122269, 86/043366), 21122-8 (00/0325-08, 679/022243, 679/022304, 679/022451, 679/042209, 679/042214, 679/052319, 679/102368, 86/043368). 4. Article Number (Lot Numbers): 21123-4 (00/0810-06, 679/052014, 679/062216), 21124-4 (679/042333, 679/062217, 679/072346), 21127-6 (679/052228), 21128-6 (679/042341).
Quantity Affected: 322 units
Reason for Recall
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-23
Company
Lasnitzhohe
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
I.T.S. GmbH has 21 FDA actions in our database, including 17 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (I.T.S. GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does I.T.S. GmbH have FDA actions?
I.T.S. GmbH has 21 FDA actions in our database, including 17 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1593-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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