Octane-C Cervical — Class II medical device recall Z-2120-2012
Terminated recall by Exactech, Inc., reported 2012-08-08, distributed in AL, CA, CO, FL, GA, IA, IL, IN…. Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression
| Recall number | Z-2120-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Exactech, Inc., Gainesville, FL, United States |
| Recall initiated | 2012-06-15 |
| Classified | 2012-08-01 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-07-03 |
| Distributed | AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA |
| Countries outside the US | AT, AU, CA, CH, DE, ES, FR, GB, GR, IN, IT, SE |
| Quantity | 54,877 units |
| Reason classes | labeling, device malfunction |
| Serial numbers | 10MM, 11MM, 12MM |
| Model numbers | 05-010-02-0605, 05-010-02-0606, 05-010-02-0607, 05-010-02-0608, 05-010-02-0609, 05-010-02-0610, 05-010-02-0611, 05-010-02-0612 |
Product
Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
Reason for recall
Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year
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-2120-2012. 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.