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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm December 02, 2015
Date Posted February 18, 2016
Recall Status1 Terminated 3 on July 18, 2019
Recall Number Z-0822-2016
Recall Event ID 72749
510(K)Number K111825  
Product Classification Staple, implantable - Product Code GDW
Product 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.
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 
Recalling Firm/
Manufacturer		 Medtronic
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall		 Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use
FDA Determined
Cause 2		 Process control
Action Medtronic sent an Urgent Medical Device Recall letters dated December 2 2015 and an Updated Urgent Medical Device Recall letter dated January 13, 2016, to affected customers, via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473. For questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at (800) 882-5878.
Quantity in Commerce 2711 kits
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
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