Allen Medical Systems: Medical Device Recall in 2018 - (Recall #: Z-0642-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 6, 2017

Date Posted: February 28, 2018

Recall Number: Z-0642-2018

Event ID: 79205

Reason for Recall:

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

Status: Terminated

Product Quantity: 161 units total

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.

Voluntary or Mandated:

Voluntary: Firm initiated