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Recall Observatory FDA recall evidence

Device product

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

Z-0942-2013

January 11, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 64287
Status
Terminated
Classification
Class II
Quantity
596
Official record key
device-enforcement:Z-0942-2013

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.