Device product
IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Z-2461-2023
Product summary
- Event
- Event 92738
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0 (US)
- Official record key
device-enforcement:Z-2461-2023
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: 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, 19J0091, 20F0184
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.