PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 Laparoscopic Manual Instruments are intended for...
FDA Device Recall #Z-0721-2015 — Class II — November 17, 2014
Recall Summary
| Recall Number | Z-0721-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 17, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Endoscopy |
| Location | San Jose, CA |
| Product Type | Devices |
| Quantity | 180,573 units total |
Product Description
PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Reason for Recall
The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Lot / Code Information
42167 42169 42172 43238 43239 81309 142647 143476 143477 245841 342652 344115 345130 0442468C 0445112D 0541360D 0541361D 0641114D 0641115D 0644773D 0645377D 0647994D 06CON06071 06CON06126 07022013E 0740507D 0740834D 0741766D 0742442D 0742740D 0744063D 0744684D 0745499D 0746059D 0746497D 0747592D 0840357D 0840678D 0841358D 0842085D 0842130D 0845885D 0846565D 0847512D 9292011 0940124D 0940126D 0940127D 0941052D 0941067D 0942146D 0942277D 0942850D 0943496D 0944142D 0945209D 0945467D 0945715D 1040120D 1040385D 1040583D 1040805D 1041471D 1041627D 1041982D 1042493D 1043025D 1043102D 1043511D 1043778D 1044521D 1044523D 1046109D 1046189D 1046193D 1141605D 1141791D 1142149D 1142927D 1143476D 1143648D 1143972D 1144238D 1144345D 1144346D 1144395D 1144642D 1144656D 1144961D 1145073D 1145344D 1145810D 1145941D 1146537D 1146660D 1146661D 1240125D 1240950D 1241422D 1241512D 1242235D 1242642D 1242713D 1242929 1242929D 1243097 1243097D 1243552 1244644 1340202 1340554 1340554H 1341605 1341605H 1341606 1341606H 1341608 1341608H 1343303 1343303H 1343724 1343724H 1345516 1345516H 1346542 1346542H 1346543 1440947 1440947H 1440955 1440955H
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.