Innovasis Recalls Opteryx Variable Rescue Screws with Incorrect Size Engraving
Innovasis, Inc. is recalling 21 Opteryx Variable Rescue Screws because they are engraved with an incorrect, larger size (16 instead of 14).
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 minor labeling error (incorrect size engraving) without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Innovasis, Inc. is recalling 21 units of the Opteryx Variable Rescue Screw, Part #CP2214, Lot #1601. These medical devices are 4.5mm x 14mm screws intended for use in the Opteryx Cervical Plate System for temporary fixation of the cervical spine.
The recall was initiated because the screws are engraved with an incorrect, larger size (16 instead of 14). This labeling error could potentially lead to the use of the wrong size screw during a procedure.
The affected units were distributed in the United States, specifically in the states of California, Utah, Idaho, Texas, Ohio, and Minnesota. Healthcare providers and facilities that have received these specific screws should stop using them and contact Innovasis, Inc. for instructions on return or replacement.
The recalled product
- Product
- Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device…
- Manufacturer
- Innovasis, Inc
- Hazard
- Affected units
- 21
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 #1601
Distribution
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