Digitex Absorbable Polydiaxanone Suture, Size 2-0 recallZ-1486-2013 · Coloplast Manufacturing US, LLC · initiated May 13, 2013
Class II Terminated All recalls posted in June 2013
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 Coloplast Manufacturing US, LLC 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
Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it is mislabeled with a three year expiration date.
FDA root cause category: Incorrect or no expiration date
What the company is doing
The firm, Coloplast, sent a letter dated May 8, 2013 to its customers. The letter described the problem, the product and actions to be taken. The customers will be contacted by Coloplast Customer Service with instructions for the handling and return of any unused product. If you have any additional questions, the dedicated Customer Service number regarding this effort is 800-258-3476.
Recall details
- Recall number
- Z-1486-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 13, 2013
- Posted by the FDA
- Jun 5, 2013
- Recalling firm
- Coloplast Manufacturing US, LLC
- Quantity
- 772 units
- Product code
- GAM
- FDA submissions
- K120284
- Distribution
- US Distribution to: KY, MI, OH, PR, TX, and VA.
Product description
Digitex Absorbable Polydiaxanone Suture, Size 2-0. Catalog Number / Code of product: 52031, 5203101400. The Digitex Delivery Device is a sterile, disposable device intended to deliver a suture to the operative site. The device assists in suturing by passing a needle through the tissue to capture the suture, and suture ligation and know-typing by holding the suture.
Code information (models, lots, serial numbers)
Lots 3390331, 3390339, 3390490.
Other devices under the same FDA submission
1 device cleared under K120284 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Digitex 52031Coloplast A/S · SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE1 report
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 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page