Recall Z-0975-2013— Orthohelix Surgical Designs Inc
Class II · Terminated
Class II FDA medical device recall by Orthohelix Surgical Designs Inc, initiated 2012-10-30, terminated 2013-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.. Reason: The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire..
- Recalling firm
- Orthohelix Surgical Designs Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-30
- Terminated
- 2013-12-05
- Firm location
- Medina, OH, United States
Product description
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Reason for recall
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
Data sourced from openFDA. This site is unofficial and independent of the FDA.