Z-0492-2015Class II

Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA

Name: Z-0492-2015 Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA
Creator: Ethicon, Inc.
Published: 2014-10-17
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2014-10-17 / Terminated / root cause: sterility

FDA source

Ethicon, Inc. began a recall of Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA on 2014-10-17. FDA classified it as Class II and gives the reason as "Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0492-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Posted: 2015-01-09
Terminated: 2015-08-14
Recalling firm: Ethicon, Inc
Product: Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Product code: GAP Suture, Nonabsorbable, Silk
Reason for recall: Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
Root cause tag: sterility
FDA root cause: Other
Action: Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail.
Quantity in commerce: 2,508 each
Distribution: Nationwide Distribution
Product codes and lots: PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q06 Lots and Expiration Dates- GPP528 JUL 2018 GPP908 JUL 2018 HAB605 JAN 2019 HAE019 JAN 2019 HAE964 JAN 2019 HAP987 JAN 2019 HBB681 JAN 2019 HBB952 JAN 2019 HBE186 JAN 2019 HCB084 JAN 2019 HCB972 JAN 2019 HCE266 JAN 2019 HCE980 JAN 2019 PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q07 Lots and Expiration Dates- GPB984 JUL 2018 GPE919 JUL 2018 HAP822 JAN 2019 HBP781 JAN 2019 HCP953 JAN 2019 HCR677 JAN 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0492-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0492-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-10	2014-12-01

Product code GAP

K946173Class IIStainless Steel, Gut, Poly (Glycolide/l-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and SilkETHICON, Inc. / cleared 1995-01-09

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)