Intervertebral Fusion Device Recalled for Potential Packaging Defect
Medicrea International is recalling 5 units of IMPIX ALIF intervertebral fusion devices due to a potential packaging defect—a pinhole in the inner or outer 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 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 is a risk-of-harm product (sterile medical device with potential sterile barrier compromise) where no injuries or illnesses have been reported, fitting the criteria for Score 3 per the rubric.
Plain-English summary
Medicrea International is recalling IMPIX ALIF S/A intervertebral fusion devices (reference B15241415), lumbar spinal fusion implants. The recall affects 5 units with lot numbers 18I0824 and 19L0046, distributed nationwide in the United States.
The devices are being recalled due to a potential packaging non-conformity: a pinhole in either the inner or outer pouch could compromise the device's sterile barrier.
No injuries or illnesses have been reported. The FDA has classified this as a Class II recall.
The recalled product
- Product
- IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
- Manufacturer
- Medicrea International
- Affected units
- 5
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 (3)
- GTIN 03613720264439
- Lot Numbers: 18I0824
- 19L0046
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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