3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
Recall
- Recall Number
- Z-2057-2018
- Event Number
- 79978
- Firm
- Stryker Corporation
- FEI Number
- 2936485
- Product Code
- PPR
- Status
- Completed
- Root Cause
- Incorrect or no expiration date
- Initiated
- December 21, 2017
- Address
- 5900 Optical Ct, San Jose, CA, 95138-1400
Description
3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
Inadvertent shipment of expired units.
The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated 12/27/2017 to its customers via mail on about 12/28/2017. Customers were initially notified via phone on 12/21/2017 and 12/22/2017. The letter described the product, problem and actions to be taken. The customers were instructed to inform those individuals in the organization who need to be aware of the recall; examine stock for affected devices; quarantine and discontinue use of recalled device; complete and return the Business Reply Form to Stryker Endoscopy via fax (408-855-6314) or email ([email protected]), and if affected product is on hand segregate it and contact Stryker customer service at 1-800-624-4422 (Option 3) or email [email protected] to arrange for product return and issuance of credit or replacement (upon availability). If you have any questions, contact Director of Regulatory Affairs and Clinical Science at 408-754-2664 or email: to [email protected].
US distribution to Massachusetts only..
2 boxes (5 units per box)