Optetrak Offset Tibial Tray and Screws — Class II medical device recall Z-0137-2018
Terminated recall by Exactech, Inc., reported 2017-11-29, distributed in AL, FL, IN, ME, MN, NJ, NY, OH…. There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constraine
| Recall number | Z-0137-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2017-09-19 |
| Classified | 2017-11-20 |
| Reported by FDA | 2017-11-29 |
| Terminated | 2021-06-21 |
| Distributed | AL, FL, IN, ME, MN, NJ, NY, OH, OK, PR, VA |
| Countries outside the US | AR, AU, BR, CH, CN, CO, ES, FR, GB, IN, IT, LU, NL, TN |
| Quantity | 720 devices |
| Model numbers | 208-04-34 |
Product
Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.
Reason for recall
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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-0137-2018. 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.