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Terminated

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.

FDA Recall Z-1486-2013 · Posted 2013-06-05

Recalling FirmColoplast Manufacturing US, LLC
Recall StatusTerminated
Product CodeGAM
Date Initiated2013-05-13
Date Terminated2014-04-10
Product Quantity772 units

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.

Firm Action

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.

Root Cause

Incorrect or no expiration date

Distribution Pattern

US Distribution to: KY, MI, OH, PR, TX, and VA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120284DIGITEX SUTURE DELIVERY SYSTEM, DIGITEXPOLYPROPYLENE SUTURE CARTRIDGE SIZE 0, WITH NEEDLE AND WITHOUT NEEDLE, DIGITEXColoplast A/S · 2012-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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