Inion GRT Tack Recall Due to Defective Aluminum Pouch Seal
Inion Ltd. is recalling 36 sterile Inion GRT Tack kits distributed in Florida and North Carolina because the aluminum pouch seal was found to be slightly open.
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. The hazard is a packaging defect (slightly open seal) that compromises sterility, which is a low-risk contamination issue without reported injuries or illnesses.
Plain-English summary
Inion Ltd. is recalling 36 pieces of Inion GRT Tack, drill bit, and tack applicator kits. The affected lots are 1604006, 1505007, and 1503039. These sterile medical devices are indicated for the surgical treatment of periodontal defects and other dental procedures.
The recall was initiated because the aluminum pouch seal was noticed to be defective and slightly open. This defect compromises the sterile barrier of the packaging. The affected products were distributed in Florida and North Carolina.
Healthcare providers and consumers who have these specific lots should stop using the products and contact Inion Ltd. for further instructions or a return.
The recalled product
- Product
- Inion GRT Tack, drill bit and tack appl., 4x, Sterile. Is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures, for pre-implant and peri-implant surgery and for…
- Manufacturer
- Inion Ltd.
- Affected units
- 36
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 (3)
- Lot Number 1604006
- 1505007
- 1503039
Distribution
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