Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles...
FDA Device Recall #Z-0822-2016 — Class II — December 2, 2015
Recall Summary
| Recall Number | Z-0822-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 2, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 2711 kits |
Product Description
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers when used with the Endo GIA curved tip single use reloads can be used to blunt dissect or separate target tissue from other tissue.
Reason for Recall
Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Canada, Albania, ALGERIA, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Gabon, Georgia, Germany, Greece, Greece, Guatemala, Honduras, Hungary, Iceland, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Mauritius, Mexico, Monaco, Montenegro, Morocco, Namibia, Netherlands, Nicaragua, Nigeria, Norway, Panama, Paraguay, Peru, Poland, Portugal, Romania, Russia, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, UAE, Ukraine, United Kingdom, Uruguay, Venezuela, and Zimbabwe.
Lot / Code Information
Kit Lot numbers: 00B0203 00Z1924 00Z1992 00Z1993 00Z2030 00Z2062 00Z2063 00Z2072 00Z2081 00Z2090 00Z2098 00Z2117 00Z2119 00Z2121 00Z2122 00Z2123 00Z2124 00Z2129 00Z2130 00Z2133 00Z2138 00Z2139 00Z2143 00Z2145 00Z2146 00Z2147 00Z2148 00Z2150 00Z2151 00Z2152 00Z2153 00Z2154 00Z2155 00Z2159 00Z2160 00Z2161 00Z2163 00Z2164 00Z2166 00Z2167 00Z2171 00Z2172 00Z2174 00Z2175 00Z2176 00Z2177 00Z2179 00Z2181 00Z2182 00Z2183 00Z2184 00Z2187 00Z2190 00Z2191 00Z2192 00Z2193 00Z2194 00Z2198 00Z2199 00Z2200 00Z2201 00Z2208 00Z2209 00Z2211 00Z2212 00Z2213 00Z2216 00Z2217 00Z2220 00Z2221 00Z2222 00Z2223 00Z2224 00Z2225 00Z2233 00Z2234 00Z2237 00Z2243 00Z2244 00Z2245 00Z2249 00Z2252 00Z2254 00Z2255 00Z2265 00Z2268 00Z2272 00Z2273 00Z2287 00Z2289 00Z2304 00Z2305 00Z2306 00Z2312 00Z2315 00Z2321 00Z2322 00Z2323 00Z2325 00Z2326 00Z2327 00Z2328 00Z2351 00Z2352 00Z2353 00Z2367 00Z2391 00Z2392 00Z2396 00Z2432 00Z5001 00Z5001A BARIATRICRR1 BARIATRICRR5 BARIATRICRR7 ENDOBARIATRICR ENDOBARIATRICS ENDOTHORACICL ENDOTHORACICS ENDOTHORACICW THORACICRR1 00Z2363 00Z2364 00Z2387
Other Recalls from Medtronic
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2548-2017 | Class II | SCHRITTMACHER ANGIO X3; Item Number: 4045255423347 | May 3, 2017 |
| Z-2543-2017 | Class II | Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 4... | May 3, 2017 |
| Z-2547-2017 | Class II | CUSTOM SUTURE PACK; Item Number: US1540 and US1614 | May 3, 2017 |
| Z-2545-2017 | Class II | Best Practice Kit, Item Numbers: 00Z2064, 00Z21... | May 3, 2017 |
| Z-2544-2017 | Class II | Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 D... | May 3, 2017 |
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.