Summary
The FDA issued a Class II for Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 by Medicrea International. Reason: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant..
Details
Source
Device Recall
External ID
Z-1039-2026
Action Date
2026-01-21
Status
Ongoing
Category
device
Product Description
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Lot/Code Info: 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
Quantity Affected: 44 units
Reason for Recall
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
Distribution
US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-29
Company
Rillieux La Pape
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medicrea International has 16 FDA actions in our database, including 14 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medicrea International) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medicrea International have FDA actions?
Medicrea International has 16 FDA actions in our database, including 14 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1039-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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