Recall Z-0062-2015— Orthohelix Surgical Designs Inc
Class II · Terminated
Class II FDA medical device recall by Orthohelix Surgical Designs Inc, initiated 2014-09-19, terminated 2016-10-31. FDA's recall record names no specific 510(k) clearance for this event. 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.
- Recalling firm
- Orthohelix Surgical Designs Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-19
- Terminated
- 2016-10-31
- Firm location
- Medina, OH, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.