IMPIX DLIF Intervertebral Fusion Device Recalled for Packaging Defect
Medicrea International is recalling IMPIX DLIF intervertebral fusion devices due to potential pinholes in product packaging that could compromise sterility.
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 Class II FDA recall with no reported injuries, hospitalizations, or confirmed contamination. However, the packaging defect presents a potential risk to device sterility, which qualifies as a risk-of-harm product where injury has not yet been reported, per the rubric's High severity criterion.
Plain-English summary
Medicrea International is recalling 24 units of the IMPIX DLIF intervertebral fusion device nationwide due to a potential packaging defect. The devices have pinholes in either the inner or outer pouch of the packaging.
Pinholes in the sterile packaging could compromise the sterility of the device. This intervertebral fusion device is used in lumbar spine surgery, and any compromise to sterility could pose a risk to patient safety if the device is implanted.
This recall affects all units distributed nationwide. The specific lot numbers and REF numbers are detailed in the FDA recall notice. Patients who have received this device or healthcare providers who have these devices in inventory should contact Medicrea International for further instructions regarding the affected units.
The recalled product
- Product
- IMPIX DLIF, REF numbers: a) B16123509, b) B16123511, c) B16124009, d) B16124013, e) B16124509, f) B16124511, g) B16124513, h) B16164009, i) B16164013, j) B16165009, k) B16165013; intervertebral fusion device - lumbar
- Manufacturer
- Medicrea International
- Affected units
- 24
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) B16123509
- GTIN 03613720196341
- Lot Numbers: 20B0490
- b) B16123511
- GTIN 03613720196358
- Lot Numbers: 19G0068
- c) B16124009
- GTIN 03613720196396
- Lot Numbers: 19K0269
- d) B16124013
- GTIN 03613720196419
- Lot Numbers: 19F0715
- e) B16124509
- GTIN 03613720196440
- Lot Numbers: 19F0713
- f) B16124511
- GTIN 03613720196457
- Lot Numbers: 19F0716
- g) B16124513
- GTIN 03613720196464
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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