Device product
IMPIX ALIF S/A, REF number B15241415; intervertebral fusion device - lumbar
Z-2454-2023
Product summary
- Event
- Event 92738
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-2454-2023
Official wording
Reason: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Code information: GTIN 03613720264439, Lot Numbers: 18I0824, 19L0046
Distribution pattern: US nationwide
Derived failure modes
-
Unknown
There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.