Recall Z-1841-2014 ยท NKB Thoracolumbosacral Pedicle Screw System
SeaSpine Inc
Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the s
| Date | Jun 20, 2014 (initiated May 21, 2014) |
| Status | Terminated |
| Reason | Integra has identified through an investigation of complaints that there may be the potential for the tip of a single lot number of the UCR 3mm Hex, Large Axial Driver, 91-1123 to twist or become rounded during use. |
| Root cause | Under Investigation by firm |
| Action | Integra sent an Urgent Voluntary Medical Device Recall letter dated May 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: 1. If you have distributed the affected product, identify those customers and forward the attached Integra Medical Device Recall Notice to them. 2. Inspect your inventory of UCR 3mm Hex, Large Axial Drivers (Catalogue Number: 91- 1123). If you have product with lot number MO16090B, STOP USING IMMEDIATELY. If you have product of any other lot number, you can cont |
| Quantity | 7 |
| Distribution | US Distribution including the states of : AL, CA, OH, NM and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043232 | UCR SPINAL SYSTEM Seaspine, Dec 21, 2004 |