—#164124

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.

FDA product code: PPR — Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot No. 14239AG2, UPC 07613327055795. The expiration date marked on the box is August 2018, but it should be August 2016.

Why it was recalled

Inadvertent shipment of expired units.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

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.

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: US distribution to Massachusetts only..

Timeline

Recall initiated: 2017-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164124. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.