Medicrea recalls
3 official recalls and safety alerts involving Medicrea since 2023-08, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Medicrea or the relevant agency.
- 2026-01-21
USMedicrea International recalls Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
FDA · DeviceMedicrea InternationalUS Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.Official notice →- 2025-02-12
- US
Medicrea International recalls UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software…
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes…
FDA · DeviceMedicrea InternationalU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice → - 2023-08-30
- US
Medicrea International recalls IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion…
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.