FDA Device recall Z-0062-2015
MaxLock Extreme Mod-Foot Concave Reamer
- FDA Device
- Class II
- terminated
- Published 2014-10-15
On 2014-10-15 the FDA classified a Class II recall of MaxLock Extreme Mod-Foot Concave Reamer by Orthohelix Surgical Designs, citing incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0062-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-19 |
| Published | 2014-10-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthohelix Surgical Designs |
| Distribution | MI, MO, NC, NM, OH, PA, TN, TX, UT, VA, WA, WI |
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
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Identifiers
| code_info | Part Number: MFT-074-CC-24; Lot: 3164011 |
|---|
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-0062-2015%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.