FDA Device recall Z-1253-2018
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use by Stryker Instruments Div, citing lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1253-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-09 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Instruments Div |
| Distribution | DC |
Product
10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.
Reason
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Identifiers
| code_info | Lot Number: 17283012 UDI: (01)7613252029830 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1253-2018%22
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