Insorb Subcuticular Skin Stapler, Ref 2030 recallZ-0078-2019 · Incisive Surgical Inc · initiated Aug 29, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Incisive Surgical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Possible compromise of the sterile barrier integrity
FDA root cause category: Process control
What the company is doing
The firm initiated the recall by telephone and email on 08/209/2018. The email notice requested that immediate suspension of all distribution. The firm will arrange to recover the product.
Recall details
- Recall number
- Z-0078-2019
- Status
- Terminated
- Initiated by the company
- Aug 29, 2018
- Recalling firm
- Incisive Surgical Inc
- Quantity
- 1200 units
- Product code
- GDW
- FDA submissions
- K120373
- Distribution
- Israel
Product description
INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Code information (models, lots, serial numbers)
UDI 10867516000101 Lot Number 182801
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- INSORB 2030Coopersurgical, Inc. · Staple, Implantable1 recall107 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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