IMPIX 3D spinal implant recalled for packaging pinhole defect
Medicrea International is recalling 248 units of IMPIX 3D intervertebral fusion devices due to pinholes in the product packaging. The recall covers devices distributed nationwide.
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: The recall involves a packaging defect on a sterile medical device classified as FDA Class II. The source text explicitly states this is a 'potential for' non-conformity with no reported illnesses or injuries. This constitutes a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.
Plain-English summary
Medicrea International is recalling IMPIX 3D intervertebral fusion devices (lumbar) due to a packaging non-conformity issue. The affected units have pinholes in either the inner or outer pouch.
The recall involves 248 units distributed nationwide. Multiple reference numbers and lot numbers are affected, as specified in the FDA recall notice.
The recalled product
- Product
- IMPIX 3D, REF numbers: a) B242C09122810, b) B242C10062810, c) B242C10122810, d) B242C11062810, e) B242C11122810, f) B242C12062810, g) B242C12122810, h) B242C12123310, i) B242C13062810, j) B242C13122810, k) B242C14122810, l) B242C15122810, m)…
- Manufacturer
- Medicrea International
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 248
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) B242C09122810
- GTIN 03613720284444
- Lot Numbers: 20B0926
- 20B0984
- b) B242C10062810
- GTIN 03613720270522
- Lot Numbers: 18E0499
- c) B242C10122810
- GTIN 03613720284451
- Lot Numbers: 20B0928
- 20B0985
- d) B242C11062810
- GTIN 03613720270539
- Lot Numbers: 18D0708
- 19F0261
- e) B242C11122810
- GTIN 03613720284468
- Lot Numbers: 20B0930
- 20B0986
- f) B242C12062810
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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