Recall – Arthroscopic shaver displays wrong settings under certain conditions

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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.