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Recall Observatory FDA recall evidence

Device product

Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.

Z-0642-2018

October 06, 2017

Class II

Product summary

Firm
Allen Medical Systems
Event
Event 79205
Status
Terminated
Classification
Class II
Quantity
161 units total
Official record key
device-enforcement:Z-0642-2018

Official wording

Reason: The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.

Code information: 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

Distribution pattern: Worldwide distribution. US Nationwide, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Greece, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Netherlands, Spain, Switzerland, Taiwan, UAE, and UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.