Reported May 6, 2015 · Terminated
Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester…
Incisive Surgical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Incisive Surgical Inc · 14405 21st Ave N · Plymouth, MN · 55447-4685
Is this the product you have?
- 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.
- Lot codes and dates
- Lot 121901
- Amount recalled
- 210 cartons (containing 6 INSORB staplers per carton)
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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