Medicrea International Recall 92738
Description: IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical
Medicrea International Recall 92738 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2461-2023 |
| Event ID | 92738 |
| Event Description | IMPIX S, REF numbers: a) B15328071S, b) B15328073S, c) B15328074S, d) B15334072S, e) B15334073S, f) B15334074S; intervertebral fusion device - cervical |
| Product Type | Devices |
| Distribution | US nationwide |
| Quantity | 0 (US) |
| Recall Reason | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| Device Classification | 20230830 |
| Device Code Info | 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 |
| Center Classification Date | 20230824 |
| Recall Initiation Date | 20230712 |
| Recalling Firm | Medicrea International |
| Initial Notification | Letter |
| Similar To |