FDA-Device2022-11-09Class II
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Ethicon, Inc.
Hazard
Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
Sold states
International distribution of the country of China.
Affected count
2,280 eaches
Manufactured in
Us Highway 22 West, N/A, Somerville, NJ, United States
Products
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0150-2023Don't want to check this manually?
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