Recall Z-0797-2016— Orthofix, Inc
Class II · Terminated
Class II FDA medical device recall by Orthofix, Inc, initiated 2016-01-08, terminated 2016-11-16. It names one FDA 510(k) clearance: K151488. Product: Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).. Reason: There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention..
- Recalling firm
- Orthofix, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-08
- Terminated
- 2016-11-16
- Firm location
- Lewisville, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
Reason for recall
There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
Data sourced from openFDA. This site is unofficial and independent of the FDA.