Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-0062-2015

U.S. FDA — Device Enforcement · United States · 2014-09-19 · Class II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0062-2015
Date of alert
2014-09-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Orthohelix Surgical Designs Inc
Product category
device
Product type
Devices
Reported risk: Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.