Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0396-2014)

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 Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

Product Classification:

Class II

Date Initiated: September 7, 2012

Date Posted: December 4, 2013

Recall Number: Z-0396-2014

Event ID: 63230

Reason for Recall:

This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tightening, the potential exists for locking caps to loosen post-operatively in certain situations.

Status: Terminated

Product Quantity: 745

Code Information:

All lots

Distribution Pattern:

Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.

Voluntary or Mandated:

Voluntary: Firm initiated