Z-2057-2018Class II

3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device...

Name: Z-2057-2018 3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device...
Creator: Stryker Corporation
Published: 2017-12-21
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2017-12-21 / Completed

FDA source

Stryker Corporation began a recall of 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... on 2017-12-21. FDA classified it as Class II and gives the reason as "Inadvertent shipment of expired units". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2057-2018
Classification: Class II
Status: Completed
Initiated: 2017-12-21
Posted: 2018-06-01
Recalling firm: Stryker Corp.
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.
Product code: PPR Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures
Reason for recall: Inadvertent shipment of expired units.
FDA root cause: 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 ([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].
Quantity in commerce: 2 boxes (5 units per box)
Distribution: US distribution to Massachusetts only..
Product codes and lots: Lot No. 14239AG2, UPC 07613327055795. The expiration date marked on the box is August 2018, but it should be August 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2057-2018	Class II	Completed	Voluntary: Firm initiated	2018-06-13	2018-06-01

Product code PPR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)