Medicrea IMPIX ALIF Lumbar Fusion Devices Recalled for Packaging Defect
Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed nationwide due to a potential packaging defect with pinholes in the device pouch.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a packaging defect with no reported injuries, illnesses, or contamination incidents. The hazard is theoretical—potential sterility compromise due to packaging defects—making this a precautionary recall.
Plain-English summary
Medicrea International is recalling 11 IMPIX ALIF lumbar intervertebral fusion devices distributed in the United States. The recall was issued due to a potential packaging non-conformity issue that could present as pinholes in either the inner or outer protective pouch.
The affected devices are identified by four reference numbers (B15111209, B15111212, B15111409, and B15111412) with specific lot numbers listed in the FDA recall notice. The FDA classified this as a Class II recall.
Physicians and healthcare facilities that received affected units should contact Medicrea International for instructions. No injuries, illnesses, or contamination events related to this issue have been reported.
The recalled product
- Product
- IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
- Manufacturer
- Medicrea International
- Category
- Medical Device — Spinal Implant
- Affected units
- 11
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 (13)
- a) B15111209
- GTIN 03613720193395
- Lot Numbers: 19C0772
- b) B15111212
- GTIN 03613720193401
- Lot Numbers: 19C0775
- 19G0070
- c) B15111409
- GTIN 03613720193425
- Lot Numbers: 19E0353
- d) B15111412
- GTIN 03613720193432
- Lot Numbers: 19C0788
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.
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