I.T.S. GmbH Rim Plate Recall: Wrong Laser Marked Article Number

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Recalling firmI.T.S. GmbHAutal 28 · Lasnitzhohe, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

I.T.S. GmbH is recalling a titanium implantable Rim Plate used for bone stabilization. The recall is due to the implant having the wrong article number laser marked on it, which could lead to improper use or complications.

Why it’s dangerous

The titanium implant is designed to temporarily stabilize bone segments until the bone heals. If the article number is incorrect, the implant may not function properly, leading to potential complications during healing or removal.

Who’s affected

Patients who received the Rim Plate, 10-Hole, Left, PRS RX System with model number 21206-10 and lot code 26/F42778 are affected. Surgeons and patients using this implant are at risk of improper function due to the incorrect marking.

How to tell if you have this one

Check for the model number 21206-10 and lot code 26/F42778 on the implant. This Rim Plate is used in the PRS RX System for temporary bone stabilization.

Brand
I.T.S. GmbH
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number and lot code on the implant to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Why is this implant being recalled?

The recall is due to the titanium implant having the wrong article number laser marked on it, which could lead to improper function.

What is the model number of the affected implant?

The model number is 21206-10.

What lot code is associated with this recall?

The lot code is 26/F42778.

Take action

Contact I.T.S. GmbH

We’ve drafted a message you can send I.T.S. GmbH to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1718-2019 — I.T.S. GmbH I.T.S. GmbH

Hello,

I own a I.T.S. GmbH that is covered by recall Z-1718-2019 from I.T.S. GmbH.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1718-2019 (May 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1718-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

I.T.S. GmbH recalls Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone

Recall notice