FDA Device recall Z-0642-2018
Radiolucent Surgery Spine Frame (F70801)
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of Radiolucent Surgery Spine Frame (F70801) by Allen Medical Systems, citing the base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0642-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-06 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Allen Medical Systems |
| Distribution | US |
Product
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Reason
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Identifiers
| code_info | Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544…Serial Number: 533552 536025 536451 539585 539795 535272 536026 536452 539586 542764 535273 536027 536453 539587 544938 535274 536028 536454 539588 544939 535386 536029 536455 539589 544940 535387 536030 536456 539794 546200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0642-2018%22
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