ClearanceBrief
Recall Z-0973-2019 ยท HRX Arthroscope

Stryker Sustainability Solutions

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 tis

DateJul 27, 2018
StatusTerminated
ReasonAffected 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.
Root causeSoftware Design Change
ActionOn July 26, 2018, Stryker Sustainability Solutions sent an "URGENT MEDICAL DEVICE RECALL" Customer Notification Letter to affected consignees asking them to follow the instructions in the letter. The letter also included a risk evaluation these devices may pose to end users and their patients. According to the Urgent Medical Device Recall Customer Notification Letter there are no harms associated with the use of affected reprocessed arthroscopic shavers. 1) Noncompatible devices are rendered inactive with console and alternative surgical methods are readily available. 2) Incorrect spin speed
Quantity14,265 units
DistributionNationwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012605REPROCESSED ATHROSCOPICS BURS
Alliance Medical Corp., Nov 7, 2001