Recall Z-0127-2014— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-0127-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-04

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2013-11-04, terminated 2014-04-29. It names one FDA 510(k) clearance: K032473. Product: Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.. Reason: Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m.

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Terminated: 2014-04-29
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K032473 — DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBEStryker Instruments·cleared 2003-11-07

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

Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.

Reason for recall

Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m

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