Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bo
FDA device recall Z-0124-2007 · posted 2006-11-02 · Terminated
Recall details
- Recalling firm
- Hydrocision, Inc.
- Reason for recall
- Distal tip may become detached from the device
- Action taken
- 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
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 40 total
- Distribution
- Nationwide.
- Date initiated
- 2006-09-07
- Date posted
- 2006-11-02
- Date terminated
- 2006-12-06
- Location
- Billerica, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 (K032529) | Hydrocision, Inc. | 2003-09-16 |