Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0202-2014)

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 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

Product Classification:

Class II

Date Initiated: October 3, 2013

Date Posted: November 20, 2013

Recall Number: Z-0202-2014

Event ID: 66485

Reason for Recall:

Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.

Status: Terminated

Product Quantity: 2979

Code Information:

Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257

Distribution Pattern:

Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated