Home / Recalls / Allen Medical Systems / Z-0642-2018

Z-0642-2018 Class II Terminated

Recalled by Allen Medical Systems — Acton, MA

Recall Details

Product Type
Devices
Report Date
February 28, 2018
Initiation Date
October 6, 2017
Termination Date
April 3, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
161 units total

Product Description

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

Reason for Recall

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

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.

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

Other recalls by Allen Medical Systems

  • Z-1262-2018 Class II — F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table acc (February 21, 2018)
  • Z-0641-2018 Class II — Allen Medical Bow Frame Model A-70800. Surgical platform used to position patie (October 6, 2017)
  • Z-1198-2017 Class II — Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: (January 3, 2017)
  • Z-0928-2017 Class II — Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and dist (November 23, 2016)
  • Z-0959-2013 Class II — Allen Traction Boot, Modular, OT 1000 Traction Device Boot Assembly, Fracture T (February 28, 2013)