Synthes USA HQ, Inc. recalls Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengt

Recalled March 20, 2013 · FDA recall Z-0942-2013 · Synthes USA HQ

Hazard

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. · FDA Class II

Units

596

Sold at

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

Description

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.

Product

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

Manufacturer(s)

Synthes USA HQ, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →