Recall Z-0973-2019— Stryker Sustainability Solutions

Name: FDA recall Z-0973-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-27

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2018-07-27, terminated 2020-09-17. It names one FDA 510(k) clearance: K012605. 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.. 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: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2018-07-27
Terminated: 2020-09-17
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K012605 — REPROCESSED ATHROSCOPICS BURSAlliance Medical Corp.·cleared 2001-11-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.