Innovasis Recalls Nine Lots of 8.5 mm Polyaxial Pedicle Screws
Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws due to a risk of breakage. The recall covers 1,010 parts distributed in the United States.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of breakage in a spinal implant, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Innovasis, Inc. is recalling nine lots of 8.5 mm Polyaxial Pedicle Screws. The recall involves 1,010 parts distributed in the United States. The specific catalog and part numbers affected are E2S8530, E2S8535, E2S8540, E2S8545, E2S8550, E2S8555, and E2S8560 with Lot Number 1101, as well as E28540 and E28545 with Lot Number 1201. Each part is engraved with its part number and lot number.
The recall is being issued because the screws are at risk of breakage. The Excella II Polyaxial Pedicle Screw system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients.
The source text does not specify the number of patients affected or report any injuries or illnesses. Consumers and healthcare providers should check their inventory for the specific part and lot numbers listed above.
The recalled product
- Product
- Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic…
- Manufacturer
- Innovasis, Inc
- Hazard
- Affected units
- 1,010
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 (7)
- Catalog/Part No.: E2S8530
- E2S8535
- E2S8540
- E2S8545
- E2S8550
- E2S8555
- E2S8560 with Lot Number: 1101 and Catalog/Part No.: E28540
Distribution
Distribution scope not specified by the agency.
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