FDA-Device2019-10-16Class II

STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

Ethicon, Inc.
Hazard

The product does not meet certain internal strength testing specifications.

Sold states
States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States
Affected count
416 each
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2020

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