TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: In
Check against the official notice below — it lists the full affected range.
Exactech, Inc. recalled 31,201 TRULIANT Knee System tibial inserts due to a packaging defect. 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 to numerous countries across North America, South America, Europe, Asia, Africa, and Oceania.
The recall involves multiple device identifiers and serial numbers across various lot codes. The record does not specify what remedy is available to 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: 31,201 devices Lot/code info: a. Item Number (Device Identifier; Serial number(s)): 02-022-47-1009 (10885862306067; 4904358, 4904362, 4904363, 4904365, 5103012, 5132420, 5132432, 5186119, 5186125, 5186128, 5220427, 5220428); 02-022-47-1010 (10885862306074; 5054265, 5054269, 5054272, 5058395, 5058402, 5063328, 5063330, 5063335, 5063336, 5143808, 5143812); 02-022-47-1011 (10885862306081; 4715514, 4849121, 5101155, 5101164, 5108302, 5108315); 02-022-47-1012 (10885862306098, 5059598, 5059599, 5059601, 5073330, 5073334, 5073349, 5073352, 5073359, 5073378); 02-022-47-1013 (10885862306104; 4758320, 4758326, 4904379, 4904391, 5101413, 5153301, 5153309, 5153317, 5174543, 5174555); 02-022-47-1015 (10885862306128; 4904313, 4904317, 4904331, 5103330, 5124929, 5217018); 02-022-47-1509 (10885862306142; 5036961, 5036979, 5036982, 5058640, 5058655, 5058656, 5058657, 5101225, 5101226, 5101229, 5101231, 5101232, 5101238, 5168416, 5168417, 5168422, S235767); 02-022-47-1510 (10885862306159; 5085658, 5085662, 5085668, 5085681, 5085682, 5085705, 5085707, 5085718, 5085721, 5085722, 5085728, 5148139, 5148140, 5148147, 5230312, 5230322, 5390682); 02-022-47-1511 (10885862306166; 4998108, 4998112, 4998120, 4998128, 4998131, 4998133, 4998138, 5010573, 5010577, 5010578, 5063133, 5152788, 5152794, 5254482); 02-022-47-1512 (10885862306173; 5057888, 5057891, 5057895, 5057897, 5057926, 5128943, 5128946, 5174523, 5174535, 5174541, 5373484, 5373486); 02-022-47-1513 (10885862306180; 5036901, 5036902, 5036906, 5036935, 5091477, 5155207, 5254
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.