FDA-Device2013-03-13Class II

Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

Synthes USA HQ, Inc.
Hazard

It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.

Sold states
Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
Affected count
18
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Synthes Multi-Vector Distractor - Multi-axial Mandible Distractor (Left), Part Number 487.967. For mandibular bone lengthening.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0905-2013

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