Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0405-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Synthes Implant Holder for Synfix (TM)-LR the Synthes Implant Holder for Synfix (TM)-LR is a non-powered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery

Product Classification:

Class II

Date Initiated: October 8, 2013

Date Posted: December 4, 2013

Recall Number: Z-0405-2014

Event ID: 66577

Reason for Recall:

Complaints were received which described the SynFix LR implant holder breaking at the interface between the implant and the holder.

Status: Terminated

Product Quantity: 548

Code Information:

all lots of part no. 03.802.039

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Canada .

Voluntary or Mandated:

Voluntary: Firm initiated