Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-0492-2015

October 17, 2014

Class II

Product summary

Firm
Ethicon, Inc.
Event
Event 69787
Status
Terminated
Classification
Class II
Quantity
2,508 each
Official record key
device-enforcement:Z-0492-2015

Official wording

Reason: Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

Code information: 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

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.