Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Check against the official notice below — it lists the full affected range.
Exactech, Inc. recalled 2,217 units of its Vantage Total Ankle System, which includes both fixed-bearing and mobile-bearing polyethylene liner components. The recall was initiated because the inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. The affected devices were distributed worldwide, including throughout the United States and in numerous other countries.
The specific affected products include item numbers 350-21-01 and 350-21-02, with detailed serial numbers provided for identification. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Reason for recall: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. Distribution: Worldwide distribution - US Nationwide distribution and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, ECUADOR, FRANCE, FRENCH POLYNESIA, GERMANY, GHANA, GREAT BRITAIN, GREECE, GUATEMALA, INDIA, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, POLAND, PORTUGAL, ROMANIA, SING Quantity: 2,217 devices Lot/code info: a. Item Number (Device Identifier; Serial number(s)): 350-21-01 (10885862276216; 4833710, 4833714, 4833715, 4833717, 4833723, 5188005, 5188007, 5188008, 5188009, 5188011, 5188013, 5188015, 5188017, 5188021, 5188022, 5188023, 5939820, 5939826, 5939831, 5939832, 5939833, 5939835, 5939836, 5939837, 5939838, 5939839, 5939840, 5939841, 5939842, 5939844, 5939845, 5939846, 6015553, 6015554, 6015556, 6015557, 6015560, 6015563, 6015566, 6015567, 6015569, 6396486, 6396489, 6396493, 6396495, 6396500, 6396504, 6396505, 6489379, 6489381, 6489382, 6489384, 6489386, 6606659, 6606667, 6606678, 6860126, 6860127, 6900582, 6900585, 6900588, Z060698, Z060703, Z060715, Z064072, Z064105, Z064107); 350-21-02 (10885862276223; 4536664, 4536665, 4536666, 4536668, 4536669, 4536670, 4536672, 4842955, 4842956, 4842957, 4842958, 4842959, 5184645, 5184647, 5184648, 5184649, 5184651, 5184652, 5184653, 5184654, 5184656, 5184657, 5184658, 5855814, 5855815, 5855816, 5855819, 5855820, 5855823, 5855824, 5855825, 5855826, 5855827, 5855828, 5855829, 5855830, 6240459, 6240461, 6240463, 6240464, 6240467, 6259881, 6259882, 6259884, 6259885, 6259888, 6356551, 6356552, 6356561, 6356562, 6356564, 6356566, 6356568, 6356569, 6356570, 6395847, 6395848, 6395852, 6395854, 6395855, 6395856, 6395858, 6395860, 6489055, 6489056, 6489059, 6489063, 6489065, 6489066, 6489069, 6489070, 6489071, 6489072, 6489073, 6583838, 6583839, 6583842, 6583843, 6583844, 6583845, 6583846, 6583849, 6583852, 6583853, 6583855, 6583857, 6730685, 67306
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.