FDAFDA · Food and drugs·Recall number Z-1681-2014
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).
Published June 11, 2014 · Recall initiated: April 8, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- US Distribution including the states of FL, NJ and MN.
- Lot
- Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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