Radiolucent Surgery Spine Frame recall
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Why was Radiolucent Surgery Spine Frame recalled?
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
- Recalling firm
- Allen Medical Systems
- Quantity
- 161 units total
- Distribution
- 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.
- Recall date
- February 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)