FDA Device recall Z-0953-2013
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508
- FDA Device
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508 by Exactech, citing A dimensional mismatch was identified which can potentially allow for interference between devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0953-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-01 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Exactech |
| Distribution | US |
Product
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Reason
A dimensional mismatch was identified which can potentially allow for interference between devices.
Identifiers
| code_info | Catalog # 02-012-42-3508 All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0953-2013%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.