FDA-Device2020-08-12Class II
SUTUREFIX ULTRA Suture, Product number 72203855
Smith & Nephew, Inc.
Hazard
A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
Sold states
Domestic distribution to AL AR AZ CO GA IL IN KS KY MD MN MO NC NE NJ NY OK PA PR TN TX VA WI. Foreign distribution to Australia Austria Belgium Finland France Germany Great Britain Ireland Italy Japan Luxembourg Mexico Netherlands Poland Portugal Singapore South Africa Spain Sweden Switzerland
Affected count
868
Manufactured in
150 Minuteman Rd, Andover, MA, United States
Products
SUTUREFIX ULTRA Suture, Product number 72203855
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2746-2020Don't want to check this manually?
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