Orca1

Drug recall

GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿…

FDA recall event 92738 · Class II · Medicrea International

Key facts

Event ID 92738
Recall numbers Z-2452-2023, Z-2453-2023, Z-2454-2023, Z-2455-2023, Z-2456-2023, Z-2457-2023, Z-2458-2023, Z-2459-2023, Z-2460-2023, Z-2461-2023, Z-2462-2023
Recalling firm Medicrea International
Product type Devices
Products GRANVIA-C, REF numbers: a)¿¿¿¿¿ A13111427, b)¿¿¿¿ A13112567, c)¿¿¿¿¿ A13113456, d)¿¿¿¿ A13131516, e)¿¿¿¿ A13131789, f)¿¿¿¿¿¿ A13132012, g)¿¿¿¿¿ B13111014, h)¿¿¿¿ B13111015, i)¿¿¿¿¿¿ B13111016…, IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j)…, IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar, IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar, IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical and 6 more
Classification Class II
Status Ongoing
Voluntary or mandated Firm Initiated
Reason for recall There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Initiation date Jul 12, 2023
Report date Aug 30, 2023
City Rillieux La Pape
Country France
FEI number 1000432246

At a glance

  • 10–99 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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