IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Reported: August 30, 2023 Initiated: July 12, 2023 #Z-2453-2023
Product Description
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar
Reason for Recall
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Details
- Recalling Firm
- Medicrea International
- Units Affected
- 11 units
- Distribution
- US nationwide
- Location
- Rillieux La Pape, N/A
Frequently Asked Questions
What product was recalled? ▼
IMPIX ALIF, REF numbers: a) B15111209, b) B15111212, c) B15111409, d) B15111412; intervertebral fusion device - lumbar. Recalled by Medicrea International. Units affected: 11 units.
Why was this product recalled? ▼
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 30, 2023. Severity: Moderate. Recall number: Z-2453-2023.
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