Device product
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).
Z-1681-2014
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 68006
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-1681-2014
Official wording
Reason: Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
Code information: Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.
Distribution pattern: US Distribution including the states of FL, NJ and MN.
Derived failure modes
-
Unknown
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.