ArthroCare Corporation recalls Speed Stitch Needle Cassette

Recall date

August 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2999-2020

FDA classification

Class II

Brand / firm

ArthroCare Corporation

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Speed Stitch Needle Cassette