FDA Device recall Z-1681-2014
Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device by Synthes, citing two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1681-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-08 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes |
| Distribution | FL, MN, NJ |
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).
Reason
Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.
Identifiers
| code_info | Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1681-2014%22
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