Back 2 Basics Recalls Dymaxeon 5.5 Curved Spinal Rods Due to Labeling Error
Back 2 Basics Direct LLC is recalling 10 Dymaxeon 5.5 Curved Rods because packages labeled as 110mm may contain 100mm rods.
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 is a labeling error regarding product dimensions, which fits the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Back 2 Basics Direct LLC is recalling 10 units of Dymaxeon 5.5 Curved Rods, Model Number 06.6441B, Lot 779C4. The recall is due to a labeling discrepancy where packages labeled as containing 110mm rods may actually contain 100mm rods.
The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The affected products were distributed to Ohio.
Healthcare providers and patients should stop using the affected rods and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the…
- Manufacturer
- Back 2 Basics Direct LLC
- Hazard
- Affected units
- 10
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 (1)
- Lot 779C4
Distribution
Distributed in 1 state:
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