Recall Z-0656-2017— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2016-10-31, terminated 2017-06-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.. Reason: Non-conforming material used..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-31
- Terminated
- 2017-06-12
- Firm location
- West Chester, PA, United States
Product description
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Reason for recall
Non-conforming material used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.