CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report
Impix S recalled by Medicrea International
Medicrea International is recalling Impix S, distributed nationwide in the US. The recall was initiated on 12 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2461-2023
- FDA event ID
- 92738
- Recalling firm
- Medicrea International, Rillieux La Pape, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jul 2023
- FDA classified
- 24 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Spinal Implants
Timeline
| 12 Jul 2023 | Recall initiated by company | |
| 24 Aug 2023 | Classified by FDA | +43 days |
| 30 Aug 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Where it was distributed
US nationwide
Questions about this recall
Why was it recalled?
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Which lots are affected?
a) B15328071S, GTIN 03613720195535, Lot Numbers: 19I0696, 20A0759; b) B15328073S, GTIN 03613720195573, Lot Numbers: 20B0747; c) B15328074S, GTIN 03613720195597, Lot Numbers: 19I0698; d) B15334072S, GTIN 03613720195832, Lot Numbers: 19I0557, 20F0185; e) B15334073S, GTIN 03613720195856, Lot Numbers: 19J0947; f) B15334074S, GTIN 03613720195870, Lot Numbers: 19E0502, 19J0091, 20F0184
Where was it sold?
US nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 92738More recalls from Medicrea International
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medicrea, IB3D Universal Implant Inserter recalled | Medicrea International | Other | Nationwide |
| Device | CLASS II | Medicrea, IB3D PL Instruments Set recalled by Medicrea International | Medicrea International | Other | Nationwide |
| Device | CLASS II | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer recalled | Medicrea International | Device Malfunction | 50 states |
| Device | CLASS II | Impix Alif S/a recalled by Medicrea International | Medicrea International | Packaging Defects | Nationwide |
| Device | CLASS II | PASS LP recalled by Medicrea International | Medicrea International | Packaging Defects | Nationwide |
Other Spinal Implants recalls
All 1,159| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |