Digitex Absorbable Polydiaxanone Suture — Class II medical device recall Z-1486-2013
Terminated recall by Coloplast Manufacturing US, LLC, reported 2013-06-12, distributed in KY, MI, OH, PR, TX, VA. Coloplast is conducting a recall on three lots of Digitex Absorbable Polydiaxanone Suture, Size 2-0 because it
| Recall number | Z-1486-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coloplast Manufacturing US, LLC, Minneapolis, MN, United States |
| Recall initiated | 2013-05-13 |
| Classified | 2013-06-05 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-04-10 |
| Distributed | KY, MI, OH, PR, TX, VA |
| Quantity | 772 units |
| Reason classes | labeling |
| Lot numbers | 3390331, 3390339, 3390490 |
Product
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.
Reason for recall
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.
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-1486-2013. 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.