Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0942-2013)

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 Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.

Product Classification:

Class II

Date Initiated: January 11, 2013

Date Posted: March 20, 2013

Recall Number: Z-0942-2013

Event ID: 64287

Reason for Recall:

There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.

Status: Terminated

Product Quantity: 596

Code Information:

All Lots

Distribution Pattern:

Worldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated