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.
FDA Recall Z-0127-2014 · Posted 2013-11-01
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHRX
Date Initiated2013-11-04
Date Terminated2014-04-29
Product Quantity20,385 total distributed since 2004
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
Firm 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].
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution including the states of AR, AZ, CA, CO, FL, GA, IL, KS, MS, ND, and NE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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