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U.S. Department of Health and Human Services

Class 2 Device Recall DRILOK THREADED CANNULA

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  Class 2 Device Recall DRILOK THREADED CANNULA see related information
Date Initiated by Firm December 21, 2017
Create Date June 01, 2018
Recall Status1 Completed
Recall Number Z-2057-2018
Recall Event ID 79978
Product Classification Surgical cannulaes & depth gauge kit for athroscopic pocedures - Product Code PPR
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.
Code Information Lot No. 14239AG2, UPC 07613327055795.  The expiration date marked on the box is August 2018, but it should be August 2016.
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact
800-624-4422
Manufacturer Reason
for Recall		 Inadvertent shipment of expired units.
FDA Determined
Cause 2		 Incorrect or no expiration date
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 (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.
Quantity in Commerce 2 boxes (5 units per box)
Distribution US distribution to Massachusetts only..
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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