Cervical intervertebral fusion devices recalled for packaging defect
Medicrea International is recalling IMPIX S cervical intervertebral fusion devices due to a potential packaging defect involving pinholes in the inner or outer pouch. No injuries have been reported.
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: This is an FDA Class II recall involving a packaging non-conformity without any reported injuries or adverse events. A pinhole in medical device packaging represents a precautionary concern rather than an acute hazard.
Plain-English summary
Medicrea International is recalling IMPIX S intervertebral fusion devices nationwide due to potential packaging non-conformity. Pinholes may appear in either the inner or outer pouch of the product packaging.
The affected devices carry reference numbers B15328071S, B15328073S, B15328074S, B15334072S, B15334073S, and B15334074S. Affected lot numbers include 19I0696, 20A0759, 20B0747, 19I0698, 19I0557, 20F0185, 19J0947, 19E0502, 19J0091, and 20F0184.
No injuries or adverse events have been reported in connection with this packaging defect. Consumers who have received affected devices should contact Medicrea International or their healthcare provider for information about the recall and any next steps.
The recalled product
- Product
- IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
- Manufacturer
- Medicrea International
- Hazard
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) 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
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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