FDA Medical Device Recalls (openFDA)
Hydrocision, Inc.: Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663
- Recall number
- Z-0124-2007
- Recalling firm
- Hydrocision, Inc.
- Product
- Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663
- Status
- Terminated
- Initiated
- 2006-09-07
- Posted
- 2006-11-02
- Terminated
- 2006-12-06
- Reason
- Distal tip may become detached from the device
- Root cause
- Process change control
- Action
- Hydrocision contacted customers and sales reps by email on 9/6/06 advising to users to discontinue use and return recalled units.
- Quantity
- 40 total
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot Number 75GF2530
- 510(k) numbers
- ["K032529"]
- PMA numbers
- not on file
- Product code
- HRX
- Firm FEI
- 3003018854
- Firm city
- Billerica
- Firm state
- MA
- 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