Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-...
FDA Device Recall #Z-1961-2012 — Class II — June 19, 2012
Recall Summary
| Recall Number | Z-1961-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 19, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Endoscopy |
| Location | San Jose, CA |
| Product Type | Devices |
| Quantity | 6388 units |
Product Description
Stryker brand Arthroscope and Hardware Set Tray (sterilization tray); Model/Part Number: 233-032-116; Product is manufactured and distributed by Stryker Endoscopy, San Jose, CA The Arthroscope and Hardware Set Tray is used to hold and protect surgical devices during the sterilization process. Specifically this tray is used for arthroscopes and arthroscopic hardware devices. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held.
Reason for Recall
The gravity steam, Ethylene Oxide (EO) and STERRAD 100S sterilization methods are being removed from the "Instructions for Use"; due to the firm's evaluation that identified original validation was not done at worst case conditions.
Distribution Pattern
Worldwide Distribution--USA (nationwide)
Lot / Code Information
All serial/lot numbers
Other Recalls from Stryker Endoscopy
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2016 | Class II | PneumoSure XL High Flow Insufflator and Pneumo... | Mar 28, 2016 |
| Z-1831-2015 | Class II | SERFAS 90 degree Energy Probe, Part Number 279-... | Jun 3, 2015 |
| Z-0631-2015 | Class II | PKG, PENNINGTON FORCEPS, P/N 0250080242. Lapa... | Nov 17, 2014 |
| Z-0646-2015 | Class II | PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250... | Nov 17, 2014 |
| Z-0679-2015 | Class II | PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparo... | Nov 17, 2014 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
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.