Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
FDA Recall Z-1251-2018 · Posted None
Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeJDZ
Date Initiated2017-11-09
Date Terminated2019-04-16
Product Quantity30
Reason for Recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Firm Action
Letters dated November 16, 2017, were sent to customers.
Actions to be taken by the Customer/User:
1. Immediately review this Recall Notification.
2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility.
3. Quarantine and discontinue use of the recalled devices.
4. Complete and sign the enclosed Business Reply Form (BRF).
5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF.
6. Return the completed BRF to Stryker Instruments Post Market Regulatory Compliance via fax (866-521- 2762) or email ([email protected]).
7. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account.
8. Report any adverse events associated with the use of these devices to Stryker Instruments 1-800-253-3210, including any infections potentially associated with the use of affected product.
Root Cause
Environmental control
Distribution Pattern
Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.