Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-0585-2016)

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; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.

Product Classification:

Class II

Date Initiated: December 1, 2015

Date Posted: January 13, 2016

Recall Number: Z-0585-2016

Event ID: 72774

Reason for Recall:

The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm.

Status: Terminated

Product Quantity: 65

Code Information:

Part number: 352.135; Lot number: F-17180

Distribution Pattern:

US nationwide distibution.

Voluntary or Mandated:

Voluntary: Firm initiated