Use caution Medical device recall · FDA · Published October 29, 2025

Medicrea IB3D PL Instruments Set Recall: Handle May Untread From Shaft

Medicrea recalls IB3D PL Instruments Set (Rx Only) with serial numbers SPS03174 due to handle potentially untreading from shaft, causing inability to rotate implants.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1039-2026Medical device Medicrea ›

Use caution until it’s fixed

Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Take action

Contact the company

Recalling firmMedicrea International5389 route de Strasbourg, Vancia · Rillieux La Pape, France

✎ GovInfoNow plain-language explainer

Medicrea is recalling its IB3D PL Instruments Set (Rx Only) with specific serial numbers because the rotation tool handle might detach from the shaft. This could prevent proper implant rotation during surgery, posing a risk to surgical outcomes. Read more at govinfonow.com/recall/50885-medicrea-ib3d-pl-instruments-set-recall-handle-may-untread-from.

Source Summary by GovInfoNow · govinfonow.com/recall/50885-medicrea-ib3d-pl-instruments-set-recall-handle-may-untread-from · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1039-2026

Cite this page

“Medicrea IB3D PL Instruments Set Recall: Handle May Untread From Shaft.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50885-medicrea-ib3d-pl-instruments-set-recall-handle-may-untread-from. Based on FDA recall #Z-1039-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1039-2026%22&limit=1).

The FDA announced on Oct. 29, 2025, that Medicrea International is recalling the Medicrea IB3D PL Instruments Set due to a handle that may untread from the shaft. This defect can result in the inability to rotate an implant during surgery.

How to tell if you have it

Brand: Medicrea
Product: Medicrea, IB3D PL Instruments Set
REF: SPS03174
Lot codes: 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016, 0017, 0018, 0020, 0021, 0024, 0025, 0026, 0029
UDI: SPS03174

The hazard

According to the FDA, orthopedic rotation tool handles may untread from the shaft. This failure results in the inability to rotate an implant.

Context

GovInfoNow's records show Medicrea International has had 8 other recalls since June 27, 2019. Other recent recalls of similar products include a Medline medical convenience kit recall on Feb. 27, 2026, and a Merit Medical Custom Procedure Kit Recall on Dec. 4, 2025.

How to tell if you have this one

Check the serial number on the product label, which should be SPS03174. The affected units include specific lot numbers: 0001 through 0018 (excluding 0015 and 0019).

Brand
Medicrea
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

Recall number	Product, codes & lots
Z-1038-2026	Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000; Lot# 21J0410, 21J0414, 21J0418, 25A0023, 21J0466, 21J1027/ UDI: (01)03613720286677
Z-1039-2026	Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174; Lot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number SPS03174 on the product label to confirm if it is affected.
Contact Medicrea
Reach out to Medicrea directly for further instructions or to confirm if your specific unit is affected.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

FDA distribution: “US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Minnesota, North Carolina, Ohio, Rhode Island, Tennessee, Texas, Virginia.

Recall timeline

FDA published this recall 3 months after the firm started it.

Oct 29, 2025Firm started the recall
Jan 9, 2026FDA classified it Class II
Jan 21, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/50885-medicrea-ib3d-pl-instruments-set-recall-handle-may-untread-from">Medicrea IB3D PL Instruments Set Recall: Handle May Untread From Shaft (GovInfoNow)</a>

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-1039-2026 (October 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1039-2026 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.