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Medicrea International FDA Recalls
14 recalls on file across devices, 0 of them Class I and 14 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174Class IIOct 29, 2025Due to complaints, orthopedic rotation tool handle may untr |
| Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000Class IIOct 29, 2025Due to complaints, orthopedic rotation tool handle may untr |
| UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-bClass IIDec 3, 2024Due to software anomalies that may impact on rod planning sp |
| IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbarClass IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B153340Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B2024020Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion devicClass IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B2018176Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B201719Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B1612451Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A131Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B023165Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122Class IIJul 12, 2023There is a potential for a product packaging non-conformity |
| IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B159Class IIJul 12, 2023There is a potential for a product packaging non-conformity |