FDA Device recall Z-0025-2022
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components
- FDA Device
- Class II
- ongoing
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components 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-0025-2022 |
| 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
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. 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 | Item Number (Device Identifier; Serial number(s)): 264-21-09 (10885862068842; 0754387, 0754388, 0754390, 0754391, 07543…Item Number (Device Identifier; Serial number(s)): 264-21-09 (10885862068842; 0754387, 0754388, 0754390, 0754391, 0754392, 0754393, 0754394, 0754396, 0754397, 0754398, 0754399, 0754400, 0754401, 0754402, 0754403, 0754404, 0754405, 0754406, 0754407, 0754408, 0754409, 0754410, 0754411, 0754412, 0754413, 0754414, 0754415, 0754416, 0754417, 0754418, 0754419, 0754420, 0754421, 0754422, 0754423, 0754424, 0754425, 0754426, 0754427, 0782395, 0782396, 0782397, 0782398, 0782399, 0782400, 0782401, 0782402, 0782403, 0782404, 0782405, 0782406, 0782407, 0782408, 0782409, 0782410, 0782411, 0782412, 0782413, 0782414, 0782415, 0782416, 0782417, 0782418, 0782419, 0782420, 0782421, 0782422, 0782423, 0782424, 0782425, 0782426, 0782427, 0782428, 0782429, 0782430, 0782431, 0782432, 0782433, 0782434, 0782435, 0782436, 0782437, 0782438, 0782439, 0782440, 0782441, 0782442, 0862418, 0862420, 0862422, 0862424, 0862425, 0862426, 0862427, 0862428, 0862429, 0862430, 0862431, 0862432, 0862434, 0862435, 0862436, 0862 |
|---|
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-0025-2022%22
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