Drug & Device Safety Atlas

FDA recall record · openFDA

Medicrea International

14 FDA recalls on record (2023–2025) — 14 device. 14 still ongoing.

0
Class I (most serious)
14
Class II
0
Class III
14
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or out 11
Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate impl 2
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have ha 1

Recalls

Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174 Class II 2025-10-29 Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 Class II 2025-10-29 UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b Class II 2024-12-03 IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B153340 Class II 2023-07-12 IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B2024020 Class II 2023-07-12 IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B2018176 Class II 2023-07-12 IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion devic Class II 2023-07-12 GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A131 Class II 2023-07-12 IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B201719 Class II 2023-07-12 IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B1612451 Class II 2023-07-12 IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122 Class II 2023-07-12 IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B159 Class II 2023-07-12 PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B023165 Class II 2023-07-12 IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar Class II 2023-07-12

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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