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.
This recall has been completed (originally issued December 21, 2017).
- Company
- Stryker Corporation
- Recall Initiated
- December 21, 2017
- Recall Number
- Z-2057-2018
- Quantity
- 2 boxes (5 units per box)
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Inadvertent shipment of expired units.
Distribution
US distribution to Massachusetts only..
Lot / Code Info
Lot No. 14239AG2, UPC 07613327055795. The expiration date marked on the box is August 2018, but it should be August 2016.
Root Cause
Incorrect or no expiration date
Action Taken
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 (endorecall@stryker.com), and if affected product is on hand segregate it and contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com 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 endorecall@stryker.com.