Recall Z-2057-2018
Stryker Corporation · initiated December 21, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot No. 14239AG2, UPC 07613327055795. The expiration date marked on the box is August 2018, but it should be August 2016.
Reason for recall
Inadvertent shipment of expired units.
FDA-determined 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.
Details
- Recall number
- Z-2057-2018
- Initiated
- December 21, 2017
- Product code
- PPR – Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures
- Quantity
- 2 boxes (5 units per box)
- Distribution
- US distribution to Massachusetts only..
- Recalling firm
- Stryker Corporation, San Jose, CA