FDA Device recall Z-1251-2018
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use
- FDA Device
- Class II
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class II recall of Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for 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-1251-2018 |
| 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
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Reason
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Identifiers
| code_info | Lot Number: 17293012 UDI: (01)4546540911971 |
|---|
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-1251-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.