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ArthroCare Corporation recalls Speed Stitch Needle Cassette
Recalled September 30, 2020 · FDA recall Z-2999-2020 · ArthroCare
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. · FDA Class II
Units
6,366 needles
Sold at
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
Description
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.
Product
Speed Stitch Needle Cassette
Manufacturer(s)
ArthroCare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →