Z-0124-2007

Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard...

Name: Z-0124-2007 Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard...
Creator: Hydrocision, Inc.
Published: 2006-09-07
License: https://open.fda.gov/license/

Hydrocision, Inc. / initiated 2006-09-07 / Terminated

FDA source

Hydrocision, Inc. began a recall of Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663 on 2006-09-07. The reason FDA records is "Distal tip may become detached from the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0124-2007
Status: Terminated
Initiated: 2006-09-07
Posted: 2006-11-02
Terminated: 2006-12-06
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
Product code: HRX Arthroscope
Reason for recall: Distal tip may become detached from the device
FDA 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 in commerce: 40 total
Distribution: Nationwide.
Product codes and lots: Lot Number 75GF2530

Product code HRX

K032529Class IIHydrocision Arthrojet System with Cautery, Turboburr and Curette, Models 51300, 51310Hydrocision, Inc. / cleared 2003-09-16

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)