High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated fo...

FDA Device Recall #Z-0818-2016 — Class II — July 30, 2013

Recall Summary

Recall Number Z-0818-2016
Classification Class II — Moderate risk
Date Initiated July 30, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smith & Nephew, Inc., Endoscopy Div.
Location Mansfield, MA
Product Type Devices
Quantity 203 units

Product Description

High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.

Reason for Recall

During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.

Distribution Pattern

Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK; and, country of Japan.

Lot / Code Information

50209581 50220887 50231401 50216929 50226220 50231932 50218285 50229266 50235063 50240019 50245683 50251109 50254562 50256942 50263784 50279382 50291593 50302984 50303418 50327069 50330377 50351345 50361381 50404796 50408768 50419699 50433964 50250837 50256854 50269580 5027766 50304642 50342002 50401593 50417254

Other Recalls from Smith & Nephew, Inc., Endoscopy Div.

Recall # Classification Product Date
Z-0155-2016 Class II Smith & Nephew MOSAICPLASTY DP- Disposable Harv... Sep 10, 2015
Z-0156-2016 Class II Smith & Nephew MOSAICPLASTY DP- Disposable Harv... Sep 10, 2015
Z-0157-2016 Class II Smith & Nephew MOSAICPLASTY DP- Disposable Harv... Sep 10, 2015
Z-0158-2016 Class II Smith & Nephew MOSAICPLASTY DP- Disposable Harv... Sep 10, 2015
Z-0700-2016 Class II Biosure Ratchet Driver, Product No: 72201888 Fo... Apr 4, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.