Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Synthes Titanium Midface Distractor Recalled by Synthes USA HQ, Inc. Due to There is the potential for the anterior footplates...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Synthes USA HQ, Inc. directly.
Affected Products
Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Quantity: 596
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 5 states: CA, LA, MA, NY, PA
About Synthes USA HQ, Inc.
Synthes USA HQ, Inc. has 56 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report