Company: Stryker Sustainability Solutions
Date of Enforcement Report: 3/5/2019
Class II:
PRODUCT
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.
Recall Number: Z-0973-2019
REASON
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.
RECALLING FIRM/MANUFACTURER
Stryker Sustainability Solutions on 7/27/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
14,265 units
DISTRIBUTION
US Nationwide and International