Insorb Subcuticular Skin Stapler — Class II medical device recall Z-1545-2015
Terminated recall by Incisive Surgical Inc, reported 2015-05-06. A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expir
| Recall number | Z-1545-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Incisive Surgical Inc, Plymouth, MN, United States |
| Recall initiated | 2015-03-19 |
| Classified | 2015-04-29 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-07-08 |
| Countries outside the US | TR |
| Reason classes | labeling |
| Lot numbers | 121901 |
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 copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
Reason for recall
A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1545-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.