Chrysalis Intelligence · Sponsors · Medicrea International

Medicrea International

Rillieux-La-Pape, FR · 3 510(k) clearances · 17 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
3
2022-01-12 → 2022-04-19
Last 12 months
0
Product codes
3
Most recent
2022-04-19
Name variants in FDA filings: Medicrea International, Inc. / Medicrea International
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NKG Posterior Cervical Screw System Class II Orthopedic 1 2022-04-19
NKB Thoracolumbosacral Pedicle Screw System Class II Orthopedic 1 2022-04-08
LLZ System, Image Processing, Radiological Class II Radiology 1 2022-01-12
Safety

Recalls (17)

Class I (serious)
0
Risk of injury / death
Total recalls
17
Currently ongoing
14
Most recent
2025-10-29
DateSeverityStatusRecall # ProductCodeReason
2025-10-29 Class II Ongoing Z-1039-2026 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.
2025-10-29 Class II Ongoing Z-1038-2026 Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000 — Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.
2024-12-03 Class II Ongoing Z-1118-2025 UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-b… — Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calcu…
2023-07-12 Class II Ongoing Z-2462-2023 IMPIX MANTA+, REF numbers: a) B20171743, b) B20171753, c) B20171763, d) B20171773, e) B20171943, f) B201719… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2461-2023 IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B153340… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2460-2023 IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B2024020… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2459-2023 GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A131… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2458-2023 PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B023165… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2457-2023 IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B159… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2456-2023 IMPIX MANTA, REF numbers: a) A20150407, b) A20250407, c) A20350567, d) B20181743, e) B20181753, f) B2018176… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2455-2023 IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B1612451… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2454-2023 IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2453-2023 IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion devic… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12 Class II Ongoing Z-2452-2023 IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122… — There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2020-10-08 Class II Terminated Z-0463-2021 MEDICREA LIGAPASS TENSION PULLEY HANDLE XS- intended to provide thoracic and/or lumbar posterior stabilization for dege… — Tightening the LIGAPASS Band with this instrument, the tensioner's pliers can crush the band causing the band to break during surgery and lead to a risk of inf…
2020-01-28 Class II Terminated Z-1473-2020 Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580… — An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw inserti…
2020-01-28 Class II Terminated Z-1472-2020 Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004… — An internal component was assembled in the incorrect orientation, which may lead to the tulip head disengaging from the crew shank during or after screw inserti…
Filings

All 510(k) clearances (3)

Date K-number Device Code Class Specialty
2022-04-19 K220810 Infinity™ OCT System and PASS OCT Spinal System NKG Class II Orthopedic
2022-04-08 K220724 CD Horizon™ Spinal System and PASS LP™ Spinal System NKB Class II Orthopedic
2022-01-12 K212005 UNiD Spine Analyzer LLZ Class II Radiology
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence