FDA Device recall Z-0023-2022
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts
- FDA Device
- Class II
- ongoing
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts by Exactech, citing inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0023-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-30 |
| Published | 2021-10-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Exactech |
| Distribution | US |
Product
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: Information reflects Exactech recall expansion initiated on 02/07/2022.
Reason
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Identifiers
| code_info | a. Item Number (Device Identifier; Serial number(s)): 02-022-47-1009 (10885862306067; 4904358, 4904362, 4904363, 490436…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0023-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.