FDA-Device2020-02-26Class II

1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429

Ethicon, Inc.
Hazard

The product do not meet certain internal testing specifications.

Sold states
International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand
Affected count
133 units
Manufactured in
Us Highway 22 West, Somerville, NJ, United States
Products
1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1336-2020

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