Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0656-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: October 31, 2016
Date Posted: November 30, 2016
Recall Number: Z-0656-2017
Event ID: 75580
Reason for Recall:

Non-conforming material used.

Status: Terminated
Product Quantity: 198 units
Code Information:

Part Number 352.040 - Lot # 9947895, L084498 Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974

Distribution Pattern:

US Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated