PlainRecalls
FDA Devices Moderate Class II Terminated

Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.

Reported: November 30, 2016 Initiated: October 31, 2016 #Z-0656-2017

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.

Details

Units Affected
198 units
Distribution
US Nationwide Distribution.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.. Recalled by Synthes (USA) Products LLC. Units affected: 198 units.
Why was this product recalled?
Non-conforming material used.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0656-2017.