11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
This recall has been terminated (originally issued November 9, 2017).
- Recall Initiated
- November 9, 2017
- Terminated
- April 16, 2019
- Recall Number
- Z-1247-2018
- Quantity
- 900
- Firm Location
- Portage, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Distribution
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.
Lot / Code Info
Lot Number: 17278012 UDI: (01)7613252594307
Root Cause
Environmental control
Action Taken
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 (erin.bissonnette@stryker.com). 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.