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DRI-LOK recallZ-2057-2018 · Stryker Corporation · initiated Dec 21, 2017

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Inadvertent shipment of expired units.

FDA root cause category: Incorrect or no expiration date

What the company is doing

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].

Recall details

Recall number
Z-2057-2018
Status
Completed
Initiated by the company
Dec 21, 2017
Recalling firm
Stryker Corporation
Quantity
2 boxes (5 units per box)
Product code
PPR
Distribution
US distribution to Massachusetts only..

Product description

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 (models, lots, serial numbers)

Lot No. 14239AG2, UPC 07613327055795.  The expiration date marked on the box is August 2018, but it should be August 2016.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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