Incisive Surgical Recalls Insorb Subcuticular Skin Staplers Due to Labeling Error
Incisive Surgical Inc is recalling Insorb Subcuticular Skin Staplers in Turkey because a distributor over-labeled a portion of the lot with an incorrect expiration date.
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, but the specific defect is a minor labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Incisive Surgical Inc is recalling 210 cartons of Insorb Subcuticular Skin Staplers, specifically Lot 121901. The recall is limited to international distribution in Turkey. The product is a medical device made from an absorbable copolymer used for skin closure.
The recall was initiated because a previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The correct expiration date at the time of manufacturing was 2014-05. This labeling error could lead to the use of expired medical devices.
Consumers and healthcare providers in Turkey who possess this specific lot of Insorb Subcuticular Skin Staplers should stop using them and contact Incisive Surgical Inc for instructions on return or disposal.
The recalled product
- Product
- Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid…
- Manufacturer
- Incisive Surgical 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)
- Lot 121901
Distribution
Distribution scope not specified by the agency.
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