Medicrea IB3D Universal Implant Inserter Recall: Handle May Untread

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Recalling firmMedicrea International5389 route de Strasbourg, Vancia · Rillieux La Pape, N/A

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Medicrea is recalling its IB3D Universal Implant Inserter (Rx Only) because the rotation tool handle may untread from the shaft, making it impossible to rotate implants properly. This could lead to improper surgical outcomes if used without the fix.

Why it’s dangerous

The handle may become loose and untread from the shaft during use, preventing the tool from rotating the implant correctly. This could cause surgical complications if the implant isn't properly positioned.

Who’s affected

Orthopedic surgeons and medical professionals who use this implant inserter for surgical procedures. Those with the specific lot numbers listed are most at risk.

How to tell if you have this one

Check the product label for lot numbers: 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, or 21J1027. The product is sold under the brand Medicrea as an Rx-only implant inserter.

Brand
Medicrea
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers on the product label: 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, or 21J1027.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The handle may untread from the shaft, causing the tool to be unable to rotate implants properly during surgery.

What should I do if I have this product?

Check the product label for lot numbers. If it matches the listed numbers, contact Medicrea for instructions.

Is there a fix for this issue?

The recall record does not specify a remedy or fix.

Take action

Contact Medicrea

We’ve drafted a message you can send Medicrea to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1038-2026 — Medicrea Medicrea

Hello,

I own a Medicrea that is covered by recall Z-1038-2026 from Medicrea.

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-1038-2026 (October 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1038-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Medicrea International recalls Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

Use caution until it’s fixed