FDA-Device2020-09-30Class II
Speed Stitch Needle Cassette
ArthroCare Corporation
Hazard
Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.
Sold states
Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV. International Distribution: AE, AU, CH, DE, FI, FR, GB, HK, IE, PA, PR, PT, RU, SG, and ZA
Affected count
6,366 needles
Manufactured in
7000 W William Cannon Dr Bldg 1, N/A, Austin, TX, United States
Products
Speed Stitch Needle Cassette
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2999-2020Don't want to check this manually?
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