FDA Device recall Z-0021-2022
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX
- FDA Device
- Class II
- ongoing
- Published 2021-10-13
On 2021-10-13 the FDA classified a Class II recall of OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX 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-0021-2022 |
| 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 LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. 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)): 02-012-35-0009 (10885862001641; 1678465, 1678471, 1678474, 167848…a. Item Number (Device Identifier; Serial number(s)): 02-012-35-0009 (10885862001641; 1678465, 1678471, 1678474, 1678481, 1957753, 2006036, 2006037, 2013812, 2043308, 2092688, 2554898, 2573058, 4705904); 02-012-35-0011 (10885862001658; 1678302, 1678309, 1678312, 1963089, 2019801, 2104502, 2104504, 2363227, 2666629, 3809531, 3809537, 4760880); 02-012-35-0013 (10885862001665; 1678446, 1678450, 2092581, 2092584, 2523130); 02-012-35-0015 (10885862001672; 1677680); 02-012-35-1009 (10885862001689; 1393427, 1393428, 1393429, 1393430, 1393431, 1393432, 1393433, 1393435, 1393436, 1393437, 1393438, 1393439, 1393440, 1393441, 1398561, 1398562, 1398563, 1398564, 1398568, 1398569, 1398573, 1398575, 1398578, 1398579, 1398580, 1398581, 1398582, 1398583, 1398584, 1398586, 1398587, 1398588, 1398589, 1398590, 1469287, 1469288, 1469289, 1469290, 1469291, 1469292, 1469293, 1469294, 1469296, 1472031, 1472032, 1472033, 1472034, 1472035, 1472038, 1472040, 1472042, 1472043, 1472044, 1472046, 1472047, 1486523, |
|---|
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-0021-2022%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.