Z-2024-2014Class II

Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture...

Name: Z-2024-2014 Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture...
Creator: Aesculap, Inc.
Published: 2014-06-13
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2014-06-13 / Terminated / root cause: labeling and UDI

FDA source

Aesculap, Inc. began a recall of Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is... on 2014-06-13. FDA classified it as Class II and gives the reason as "Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2024-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-13
Posted: 2014-07-09
Terminated: 2014-10-07
Recalling firm: Aesculap Inc
Product: Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-absorbable polyamide Surgical Suture, additional label affixed on the box states the product is sterile, packaged in a cassette holding 12 sutures
Product code: GAR Suture, Nonabsorbable, Synthetic, Polyamide
Reason for recall: Aesculap Inc. (AIC (USA)) has initiated a voluntary recall of Dafilon Black 10/0 (0.2) 15 cm DRm4 non-sterile non-absorbable polyamide Surgical Suture due to a labeling issue. Box labels do state non-sterile; however there is an additional label that is affixed on the box that states the product is sterile.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: A correction and removal notification, dated June 13, 2014, was sent to end users, sales reps, and distributors which described the product, problem, and actions to be taken.
Quantity in commerce: 11
Distribution: Distributed in the states of IL, NY, GA, and RI.
Product codes and lots: Lot Numbers: 1-6375 1-8473 1-8433 1-9384 110054 110055

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2024-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2024-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-09

Product code GAR

K990090Class IIDafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. / cleared 1999-03-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)