Innovasis Recalls Excella II Titanium Spine Rods Due to Labeling Error
Innovasis is recalling two lots of Excella II titanium spine rods because they were packaged with each other's labels.
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 (mis-labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Innovasis, Inc. is recalling two lots of Excella II titanium rods intended for use in the non-cervical area of the spine. The recall involves catalog numbers SR 55100 (5.5 x 100 mm) and SR 55110 (5.5 x 110 mm), both from Lot 1502. The products were packaged in heat-sealed plastic bags or reusable steam sterilization trays as implant sets.
The recall was initiated because the two lots were packaged using each other's labels. This labeling error could lead to the use of the wrong implant size or type during surgical procedures.
A total of 17 units were distributed in the United States to California, Kansas, Ohio, and Texas. Healthcare providers and patients who have received these specific implants should contact Innovasis, Inc. for further instructions on removal or replacement.
The recalled product
- Product
- Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the…
- Manufacturer
- Innovasis, Inc
- Hazard
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)
- Catalog No.: SR55110 Lot 1502 and SR55100 Lot 1502
Distribution
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