The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1718-2019·Announced 2019-06-12

I.T.S. GmbH Recalls Titanium Rim Plates Due to Incorrect Laser Marking

I.T.S. GmbH is recalling 65 titanium rim plates because they have the wrong article number laser marked on them. The devices were distributed in the US and several international countries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect article number) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

I.T.S. GmbH is recalling 65 units of the Rim Plate, 10-Hole, Left, PRS RX System. These are titanium, implantable devices used to temporarily stabilize bone segments until bony consolidation has taken place. The recall is due to a labeling error where the devices have the wrong article number laser marked on them.

The affected devices are identified by Model Number 21206-10 and Lot Code 26/F42778. The recall covers worldwide distribution, including US nationwide distribution in the states of Florida and Puerto Rico, as well as distribution in Austria, the Netherlands, Slovenia, South Africa, and Switzerland.

This is a Class II recall. The FDA has not reported any illnesses or injuries associated with this specific labeling defect. Healthcare providers should verify the article number on the devices against their records to ensure correct identification and inventory management.

The recalled product

Product
Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
Manufacturer
I.T.S. GmbH
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
65

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 (2)

  • Model Number: 21206-10
  • Lot Code: 26/F42778

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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