Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0394-2014)

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 Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

Product Classification:

Class II

Date Initiated: October 3, 2013

Date Posted: December 4, 2013

Recall Number: Z-0394-2014

Event ID: 66580

Reason for Recall:

During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

Status: Terminated

Product Quantity: 3087

Code Information:

part 219.951 with multiple lot#: 2335941 2339634 2397429 2405812 2440475 2442736 2496414 5661855 5663841

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated