Recall Z-0867-2017— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-11-29, terminated 2017-08-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument. Reason: The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-29
- Terminated
- 2017-08-03
- Firm location
- West Chester, PA, United States
Product description
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Reason for recall
The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
Data sourced from openFDA. This site is unofficial and independent of the FDA.