Orthohelix MaxLock Reamer Recalled for Incorrect Laser-Etched Sizing
Orthohelix Surgical Designs is recalling 38 MaxLock Extreme Mod-Foot Concave Reamers because incorrect sizing was laser-etched on the devices.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves incorrect labeling (sizing) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Orthohelix Surgical Designs Inc is recalling 38 units of the MaxLock Extreme Mod-Foot Concave Reamer. The devices are individually packaged in heat-sealed bags and are used during surgical procedures to clear away bone and cartilage within the desired implant area.
The recall was initiated because incorrect sizing was being laser-etched on the reamers. The affected units have Part Number MFT-074-CC-24 and Lot 3164011.
The devices were distributed in the United States to the states of Wisconsin, New Mexico, Texas, Washington, Missouri, Ohio, Utah, Tennessee, Michigan, Virginia, North Carolina, and Pennsylvania. Healthcare providers and patients should stop using the affected reamers and contact the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- Orthohelix Surgical Designs Inc
- Hazard
- Affected units
- 38
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number: MFT-074-CC-24
- Lot: 3164011
Distribution
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