FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: 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.
- Recall number
- Z-0127-2014
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- 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.
- Status
- Terminated
- Initiated
- 2013-11-04
- Posted
- 2013-11-01
- Terminated
- 2014-04-29
- 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
- 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 kara.spath@stryker.com.
- Quantity
- 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.
- Lot, serial or model codes
- Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000.
- 510(k) numbers
- ["K032473"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 1811755
- Firm city
- Portage
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28