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RecallWatchMedical Device Safety
Class IIOngoingZ-1604-2026

I.T.S. GmbH recalls I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with th…

I.T.S. GmbHLasnitzhohe, AustriaReported Apr 1, 2026 · 3 months ago
Legal News Analyst ·

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).

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.

Lot / code information

Lot #
): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639) — +7 moreShow all
): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639), 21233-4 (26/F65640), 21233-6 (26/F61723, 26/F65046), 21234-4 (26/F65641, 26/F66504), 21235-4 (26/F65642, 26/F67810). 2. Article Number (
Lot #
): 21231-6 (643/012301, 643/022310, 643/032308, 643/0630, 643/0657, 643/102402, 643/122301). 3. Article Number (
Lot #
): 37302-18 (18/636447), 37302-20 (18/802189)

What the firm is doing

ITS initially notified its importer/distributor on about 01/23/2026 via email. Instructions were to cease distribution, and further information will be provided. An additional notification was sent to distributors and consignees on about 02/04/2026 via email. Instructions included to ensure any IFU different to the provided one is removed from systems and/or destroyed, notify clinical staff managing patients with implants, contact I.T.S. GmbH for any questions or to discuss proper scanning conditions for implanted devices in the interim while they work on labeling and IFU updates for the devices, and arrange for the return of specific originally packaged items - base plates and screws in surgery trays. Other outlined products can continue to be used upon confirmation from ITS. Consignees were also instructed to complete and return the response form. Distributors were instructed to continue to immediately halt product distribution from the U.S. office to sales groups and hospitals, remove the outdated paper IFU from packaging and add the eIFU symbol to product labeling to implement the updated IFU provided electronically - see annex "F-7.5.5-3-US_IFU_non-sterile_Rev00_DRAFT". Paper IFUs will be made available upon request. They were also requested to assist in notification of hospitals.

DistributionShow details

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.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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