Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1952-2013)

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 Flexible Medullary Reamer. Intended to be used to facilitate the preparation of the intramedullary cavity.

Product Classification:

Class II

Date Initiated: June 11, 2013

Date Posted: August 21, 2013

Recall Number: Z-1952-2013

Event ID: 65560

Reason for Recall:

Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. The potential for harm exists if there is an introduction of foreign material at the operative site originating from the presence of corrosion and/or the retained undefined material that could not be adequately cleaned.

Status: Terminated

Product Quantity: 13,050

Code Information:

All lots with part number 359.106, 359.107, 359.108, 359.109, 359.110, 359.111, 359.112, 359.113, 359.114, 359.115

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated