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.
FDA Recall Z-2057-2018 · Posted None
Recalling FirmStryker Corporation
Recall StatusCompleted
Product CodePPR
Date Initiated2017-12-21
Product Quantity2 boxes (5 units per box)
Reason for Recall
Inadvertent shipment of expired units.
Firm Action
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].
Root Cause
Incorrect or no expiration date
Distribution Pattern
US distribution to Massachusetts only..
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.