Orthohelix Surgical Designs Inc 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
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Orthohelix Surgical Designs Inc
Lot Codes / Batch Numbers
Part Number: MFT-074-CC-24, Lot: 3164011
Products Sold
Part Number: MFT-074-CC-24; Lot: 3164011
Orthohelix Surgical Designs Inc is recalling MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with l due to Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MI, MO, NM, NC, OH, PA, TN, TX, UT, VA, WA, WI
Page updated: Jan 10, 2026