Recall Z-2200-2013— Medtronic Sofamor Danek USA Inc
Class II · Terminated
Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2013-08-12, terminated 2013-12-27. FDA's recall record names no specific 510(k) clearance for this event. Product: T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.. Reason: One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip..
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-12
- Terminated
- 2013-12-27
- Firm location
- Memphis, TN, United States
Product description
T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.
Reason for recall
One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
Data sourced from openFDA. This site is unofficial and independent of the FDA.