FDA-Device2022-05-18Class II
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Ethicon, Inc.
Hazard
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Sold states
International distribution in the country of China.
Affected count
2808 (all OUS)
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2022Don't want to check this manually?
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