Innovasis Recalls Excella II Pedicle Screws Due to Mislabeling
Innovasis is recalling 32 units of Excella II Standard Pedicle Screws because the size and catalog number are mislabeled.
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 involves minor labeling errors regarding size and catalog number, which fits the Moderate severity criteria for low-risk contamination or labeling issues without reported injuries.
Plain-English summary
Innovasis, Inc. is recalling 32 units of the Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. These medical devices are used for spinal fixation and are packaged in heat-sealed plastic bags or reusable steam sterilization trays.
The recall was initiated due to mislabeling of the size and catalog number. The affected units are Lot 1301 for both catalog numbers.
The products were distributed nationwide in the United States, including Texas, California, Kansas, Minnesota, and Oklahoma, as well as to Japan. Healthcare providers and patients should stop using these specific lots and contact Innovasis for further instructions.
The recalled product
- Product
- Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
- Manufacturer
- Innovasis, Inc
- Hazard
- Affected units
- 32
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)
- E2S47525 Lot 1301 and E2S47535 Lot 1301
Distribution
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