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Terminated

HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58662

FDA Recall Z-0123-2007 · Posted 2006-11-02

Recalling FirmHydrocision, Inc.
Recall StatusTerminated
Product CodeHRX
Date Initiated2006-09-07
Date Terminated2006-12-06
Product Quantity40 total

Reason for Recall

Distal tip may become detached from the device

Firm Action

Hydrocision contacted customers and sales reps by email on 9/6/06 advising to users to discontinue use and return recalled units.

Root Cause

Process change control

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032529HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310Hydrocision, Inc. · 2003-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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