FDA Device recall Z-1254-2018
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983 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-1254-2018 |
| 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
1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2. 11g/15mm iVAS System Kit, Product Number: 0705-315-000, UDI: (01)7613252505969 for spinal orthopedic use.
Reason
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Identifiers
| code_info | 1. Shelf Life: 12 months; Lot Number: 17277012; 2. Shelf Life: 36 months; Lot Numbers: 17283012, 17299012 UDI: (01)7613252505983; (01)7613252505969 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Stryker Instruments Div recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1254-2018%22
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