Recall Z-1247-2018
Stryker Instruments Div. of Stryker Corporation · initiated November 9, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
11g Verteport Cement Cannula (18/pkg), Product Number: 0306-511-000, UDI: (01)7613252594307 for spinal orthopedic use.
Codes / lots: Lot Number: 17278012 UDI: (01)7613252594307
Reason for recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
FDA-determined 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.
Details
- Recall number
- Z-1247-2018
- Initiated
- November 9, 2017
- Terminated
- April 16, 2019
- Product code
- OAR – Injector, Vertebroplasty (Does Not Contain Cement)
- Quantity
- 900
- 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.
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation, Portage, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1243-2018 Class II | Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1244-2018 Class II | 180-Gram Cement Cartridge with Breakaway Femoral Nozzle, Product Number: 0206-530-000…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1245-2018 Class II | 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1246-2018 Class II | 1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1248-2018 Class II | Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press.…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1249-2018 Class II | PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI:…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1250-2018 Class II | 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1251-2018 Class II | Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1252-2018 Class II | Revolution CMS w/ Femoral Breakaway Nozzle & Med. Press., Product Number: 0606-573-000…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1253-2018 Class II | 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1254-2018 Class II | 1. 11g/10mm iVAS System Kit, Product Number: 0705-310-000, UDI: (01)7613252505983; 2.…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |
| Z-1255-2018 Class II | Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI:…Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. | 11/09/2017Terminated |