XTANT Medical Recalls 5.5mm CoCr Straight Rods Due to Labeling Error
XTANT Medical Inc. is recalling 97 units of 5.5mm CoCr Straight Rods because the labels may incorrectly identify the material as Ti6Al-4V ELI instead of Cobalt Chromium.
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, but the hazard is a labeling error regarding material composition without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
XTANT Medical Inc. is recalling 97 units of 5.5mm Diameter x 500mm CoCr Straight Rods, Model number X077-0420. The product is an accessory to the Fortex Pedicle Screw System, used to connect pedicle screws for spinal stabilization. The recall was initiated because the material type on the label may incorrectly state "Ti6Al-4V ELI," while the rods are actually composed of Cobalt Chromium.
The affected units are packaged in plastic bags with one piece per bag. The distribution was worldwide, including the United States (AZ, CA, CT, GA, LA, NV, OH, TX) and Mexico. The specific lot number is 041218.
Healthcare providers and patients should check their inventory for this specific model and lot number. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- 5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected…
- Manufacturer
- XTANT MEDICAL INC
- Hazard
- Affected units
- 97
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 X077-0420
- lot number 041218
Distribution
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