Recall Z-0420-2012 ยท HTW Bit, Drill
Interventional Spine Inc
Single Use PERPOS PLS System, Catalog #9045-01 Catalog#9045-01 for Single Use PERPOS PLS System- a sterile, medical device kit consisting of the components: PERPOS Access Needle, PERPOS K-Wires, PERPOS 2-in-1 Drill, PERPOS Tap, PERPOS Device Driver, 4.5mm BONE-LOK PLS Implant, and PERPOS Pull Pin Remover. The kit is used by medical professions to stablize the spine as an aid to fusion through imm
| Date | Jan 11, 2012 (initiated Feb 22, 2008) |
| Status | Terminated |
| Reason | The recall was intiated because Interventional Spine has confirmed that the PERPOS 2-in-1 Drill (6070) manufactured by a contract manufacturer for Interventional Spine, Inc., may break during use. |
| Root cause | Pending |
| Action | The recall communication was initiated on February 22, 2008 with Interventional Spine forwarding an Urgent Recall Notification to all their customers (via email). The notification informed the customers of the problem identified and instructions for the recall. If you have any questions, contact the Vice President, Quality, Regulatory and Clinical Affairs at (949) 525-1493 or email: jmetcalf@i-spineinc.com. |
| Quantity | 65 |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA, FL, MO, NY, OH, PA, TN, WA, and WI; and country of: Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.