Z-0127-2014Class II

Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that...

Name: Z-0127-2014 Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-11-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-11-04 / Terminated / root cause: design

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an... on 2013-11-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0127-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Posted: 2013-11-01
Terminated: 2014-04-29
Recalling firm: Stryker Corp.
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.
Product code: HRX Arthroscope
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
Root cause tag: design
FDA root cause: Device Design
Action: On 11/4/13, an URGENT MEDICAL DEVICE Recall Notification was sent to all domestic consignees via mail and foreign by email. An advisory was sent to every physician that uses any of the products listed. Every physician that uses any of these products must print their name and sign below which means you acknowledge that youve received a copy of the attached advisory and that you understand the information regarding the proper usage of the Decompressor. Once the form has been signed by all physicians, the form must be completed and signed by the recall coordinator. Please fax to 866-521-2762 or email to [email protected].
Quantity in commerce: 20,385 total distributed since 2004
Distribution: Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
Product codes and lots: Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0127-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0127-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

Product code HRX

K032473Class IIDekompressor Percutaneous Discectomy ProbeStryker Instruments / cleared 2003-11-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)