FDA-Device2014-06-11Class II
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
Synthes, Inc.
Hazard
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
Sold states
US Distribution including the states of FL, NJ and MN.
Affected count
3
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1681-2014Don't want to check this manually?
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