FDA-Device2014-12-10Class II

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

Ethicon, Inc.
Hazard

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

Sold states
Nationwide Distribution
Affected count
2,508 each
Manufactured in
US Highway 22 West, N/A, Somerville, NJ, United States
Products
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0492-2015

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