Medicrea IMPIX C+ Cervical Fusion Device Recalled for Packaging Defect
Medicrea is recalling IMPIX C+ cervical intervertebral fusion devices due to a potential packaging non-conformity that presents as a pinhole in the product pouch. The defect could affect product integrity for this implantable device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves an implantable cervical spine device where packaging integrity is critical for maintaining sterility. Although no injuries or illnesses have been reported, a packaging defect on a sterile implantable device constitutes a risk-of-harm product without reported injuries, fitting the criteria for High severity.
Plain-English summary
Medicrea International is recalling specific lot numbers of the IMPIX C+ cervical intervertebral fusion device due to a potential packaging non-conformity issue. The defect presents as a pinhole in either the inner or outer product pouch.
The IMPIX C+ is an implantable cervical intervertebral fusion device. Eight reference numbers are affected, with multiple lot numbers identified across the product GTINs.
The affected devices have been distributed nationwide in the United States. Patients and healthcare providers who have or may have received affected units should contact Medicrea International for further guidance.
No illnesses or adverse events related to the packaging defect have been reported.
The recalled product
- Product
- IMPIX C+, REF numbers: a) B20240104, b) B20240105, c) B20240106, d) B20240107, e) B20240205, f) B20240206, g) B20240207, h) B20240208; intervertebral fusion device - cervical
- Manufacturer
- Medicrea International
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) B20240104
- GTIN 03613720234241
- Lot Numbers: 19A0773
- 19B0524
- 19C0511
- 19E0477
- 19K0180
- b) B20240105
- GTIN 03613720234258
- Lot Numbers: 18K0653
- 18L0497
- 19A0636
- 19A0654
- 19B0189
- 19C0512
- 19C0664
- 19I0849
- 19L0701
- 20G0851
- 20H0262
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Medicrea International under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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