Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endo...
FDA Device Recall #Z-1872-2014 — Class II — May 19, 2014
Recall Summary
| Recall Number | Z-1872-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 19, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Endoscopy |
| Location | San Jose, CA |
| Product Type | Devices |
| Quantity | 1992 trays |
Product Description
Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.
Reason for Recall
STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.
Distribution Pattern
Worldwide Distribution.
Lot / Code Information
Part Number 272-700-000: Lot number: 20476.1 23541 23837 26403 26404 26405 26676 27009 27518 28341 30248 34355 35932 36756 39705 05J034834 06con05774 06CON06360 06CON06846 06con06869 06con06960 06con08587 25067-1-12 26882-1-1 26882-1-11 26882-1-12 26882-1-13 26882-1-14 35200-1-1 36610-1-1 38820-1-1 39078-1-1 40504-2-1 40675-1-1 41231-1-1 41827-1-1 42085-1-1 42375-1-1 42527-1-1 42789-1-1 43103-1-1 43589-1-1 43716-1-1 43716-1-3 43716-1-4 44568-1-10 44568-1-11 44568-1-2 44568-1-3 44568-1-4 44568-1-6 44568-1-7 44568-1-8 44568-1-9 46227-1-1 47731-1-1 48595-1-1 48596-1-1 48597-1-1 48598-1-1 48599-1-1 48600-1-1 50101-1-1 50628-1-1 50828-1-1 51237-1-1 52439-1-1 55035-1-1 55422-1-1 55462-1-1 56456-1-1 R471611 SS15329.
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
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.