F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: A166677 A201568 A311424 A333604 A353171 A385408 A166678 A201569 A311425 A339446 A357145 A385409 A170724 A201570 A314187 A339447 A359864 A385410 A179337 A209110 A319402 A348001 A362219 A386775 A182027 A209111 A320583 A348174 A364982 A386776 A183578 A209112 A320584 A348175 A369558 A386777 A188535 A209113 A322480 A348176 A369884 A386778 A194789 A282259 A322597 A348177 A370262 A390698 A194790 A282260 A325663 A348178 A372387 A390699 A197337 A282537 A325664 A348179 A378593 A390700 A197338 A282538 A326358 A352174 A378594 A390701 A197339 A309460 A331161 A352175 A378595 A390702 A197554 A309461 A331162 A352176 A378596 A390703 A198334 A309462 A331163 A352177 A378597 A395121 A198335 A309463 A333601 A353168 A384029 A395122 A198336 A309464 A333602 A353169 A384329 A395123 A201567 A309465 A333603 A353170 A384330
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Allen Medical Systems
Reason for Recall:
The recalling firm has become aware that the rail section clamps used to attach the leg support of the device may fail during use, which could result in critical harm to the patient.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

Product Codes/Lot Numbers:

Serial Numbers: A166677 A201568 A311424 A333604 A353171 A385408 A166678 A201569 A311425 A339446 A357145 A385409 A170724 A201570 A314187 A339447 A359864 A385410 A179337 A209110 A319402 A348001 A362219 A386775 A182027 A209111 A320583 A348174 A364982 A386776 A183578 A209112 A320584 A348175 A369558 A386777 A188535 A209113 A322480 A348176 A369884 A386778 A194789 A282259 A322597 A348177 A370262 A390698 A194790 A282260 A325663 A348178 A372387 A390699 A197337 A282537 A325664 A348179 A378593 A390700 A197338 A282538 A326358 A352174 A378594 A390701 A197339 A309460 A331161 A352175 A378595 A390702 A197554 A309461 A331162 A352176 A378596 A390703 A198334 A309462 A331163 A352177 A378597 A395121 A198335 A309463 A333601 A353168 A384029 A395122 A198336 A309464 A333602 A353169 A384329 A395123 A201567 A309465 A333603 A353170 A384330

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1262-2018

Related Recalls

During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.

Jan 3, 2017 Implants & Prosthetics View Details →