Optetrak Logic Comprehensive Knee Prosthesis System — Class II medical device recall Z-0953-2013
Terminated recall by Exactech, Inc., reported 2013-03-27, distributed nationwide. A dimensional mismatch was identified which can potentially allow for interference between devices.
| Recall number | Z-0953-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2013-02-01 |
| Classified | 2013-03-15 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2014-09-22 |
| Distributed | Nationwide (US) |
| Quantity | 123 devices |
| Model numbers | 02-012-42-3508 |
Product
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Reason for recall
A dimensional mismatch was identified which can potentially allow for interference between devices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0953-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.