Recall Z-1251-2018— Stryker Instruments Div. of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2017-11-09, terminated 2019-04-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-09
- Terminated
- 2019-04-16
- Firm location
- Portage, MI, United States
Product description
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Reason for recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Data sourced from openFDA. This site is unofficial and independent of the FDA.