FDA-Device2019-10-16Class II
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 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
852 each
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0048-2020Don't want to check this manually?
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