Recall Z-0124-2007 ยท HRX Arthroscope
Hydrocision, Inc.
Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663
| Date | Nov 2, 2006 (initiated Sep 7, 2006) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032529 | HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS 51300, 51310 Hydrocision, Inc., Sep 16, 2003 |