CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Medicrea, IB3D PL Instruments Set recalled by Medicrea International

Medicrea International is recalling Medicrea, IB3D PL Instruments Set, distributed nationwide in the US. The recall was initiated on 29 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 0001, 0002, 0003, 0004, 0005, 0006, 0008, 0009, 0010, 0011, 0012, 0013, 0014, 0016 ,0017 ,0018, 0020, 0021, 0024, 0025, 0026, 0029/UDI: SPS03174

Quantity recalled44 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1039-2026
FDA event ID: 97996
Recalling firm: Medicrea International, Rillieux La Pape
Classification: Class II
Status: Ongoing
Recall initiated: 29 Oct 2025
FDA classified: 9 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 Oct 2025	Recall initiated by company
9 Jan 2026	Classified by FDA	+72 days
21 Jan 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

Where it was distributed

US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

Nationwide California Florida Minnesota North Carolina Ohio Rhode Island Tennessee Texas Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97996

Reported	Class	Recall	Company	Reason	Where
21 Jan 2026	CLASS II	Medicrea, IB3D Universal Implant Inserter recalled	Medicrea International	Other	Nationwide

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21 Jan 2026Device	CLASS II	Medicrea, IB3D Universal Implant Inserter recalled	Medicrea International	Other	Nationwide
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