PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: December 10, 2014 Initiated: October 17, 2014 #Z-0492-2015

Product Description

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

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.

Details

Recalling Firm
Ethicon, Inc.
Units Affected
2,508 each
Distribution
Nationwide Distribution
Location
Somerville, NJ

Frequently Asked Questions

What product was recalled?
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.. Recalled by Ethicon, Inc.. Units affected: 2,508 each.
Why was this product recalled?
Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 10, 2014. Severity: Moderate. Recall number: Z-0492-2015.