Recall Z-1038-2016— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1038-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-04

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2016-02-04, terminated 2017-05-09. It names one FDA 510(k) clearance: K904172. Product: (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.. Reason: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility..

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-02-04
Terminated: 2017-05-09
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K904172 — ACCUPLACE (TM)Dlp, Inc.·cleared 1990-11-21

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) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

Reason for recall

During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

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