Medicrea Recalls IMPIX TLIF Fusion Devices for Packaging Defects
Medicrea International is recalling IMPIX TLIF intervertebral fusion devices due to potential packaging defects. The devices may have pinholes in the inner or outer packaging pouches.
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 with no reported illnesses, injuries, or confirmed harm. The issue is a potential packaging defect detected proactively, falling under the 'voluntary precautionary recalls' category of Moderate severity.
Plain-English summary
Medicrea International is recalling 730 IMPIX TLIF intervertebral fusion devices, which are lumbar intervertebral fusion devices, distributed nationwide in the United States.
The recall is due to a potential packaging non-conformity issue. Pinholes may be present in either the inner or outer pouch of the product packaging.
Patients and healthcare providers should contact Medicrea International for further information and instructions regarding the recalled devices.
The recalled product
- Product
- IMPIX TLIF, REF numbers: a) B15130607S, b) B15130609S, c) B15130611S, d) B15130613S, e) B15130615S, f) B15900806, g) B15900906, h) B15901006, i) B15901106, j) B15901206, k) B15901306; intervertebral fusion device - lumbar
- Manufacturer
- Medicrea International
- Hazard
- Affected units
- 730
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) B15130607S
- GTIN 03613720245681
- Lot Numbers: 19B0894
- 19C0092
- 19G0921
- 19G0922
- 19L0045
- 20B0320
- 20B0477
- 20B0478
- 20B0479
- b) B15130609S
- GTIN 03613720245674
- Lot Numbers: 18D1077
- 19J0690
- 20A0042
- 20A0423
- 20A1000
- 20B0322
- 20B0476
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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