Recall Z-1253-2018— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1253-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-09

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2017-11-09, terminated 2019-04-16. It names one FDA 510(k) clearance: K123942. Product: 10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.. Reason: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-11-09
Terminated: 2019-04-16
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K123942 — STRYKER IVAS BALLOON CATHETERStryker Corporation·cleared 2013-04-03

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

10g/15mm (15/2) iVAS System Kit, Product Number: 0705-115-000, UDI: (01)7613252029830 for spinal orthopedic use.

Reason for recall

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

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