MaxLock Extreme Mod-Foot Concave Reamer — Class II medical device recall Z-0062-2015
Terminated recall by Orthohelix Surgical Designs Inc, reported 2014-10-15, distributed in MI, MO, NC, NM, OH, PA, TN, TX…. Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
| Recall number | Z-0062-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthohelix Surgical Designs Inc, Medina, OH, United States |
| Recall initiated | 2014-09-19 |
| Classified | 2014-10-09 |
| Reported by FDA | 2014-10-15 |
| Terminated | 2016-10-31 |
| Distributed | MI, MO, NC, NM, OH, PA, TN, TX, UT, VA, WA, WI |
| Quantity | 38 |
| Lot numbers | 3164011 |
| Model numbers | MFT-074-CC-24 |
Product
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.
Reason for recall
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
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-0062-2015. 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.