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Skytron Spine Frame
COMPOSITE MANUFACTURING, INC. · Model 3-090-01 · UDI-DI 00810105030686
10
510(k) clearances
225
Adverse events (1 deaths)
74
Recalls
152
Facilities
Description
Radiolucent Spine positioning traction frame. Arcing flexures are used to arc the patients spine while in the prone position to expose the spine for surgical procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-13 | Innovative Orthopedic Technologies, LLC | Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
| 2016-10-06 | The Anspach Effort, Inc. | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
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