Stryker Sustainability Solutions product recalled over fire hazard

Recall date

July 27, 2018

Source

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

Official notice title

Stryker Sustainability Solutions recalls Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut…

Recall number

Z-0973-2019

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

Nationwide Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. OUS Israel and Canada.

Why it was recalled

Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.

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

What was recalled

Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.