CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Radiolucent Surgery Spine Frame (F70801) recalled
Allen Medical Systems is recalling Radiolucent Surgery Spine Frame (F70801), distributed nationwide in the US. The recall was initiated on 6 Oct 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0642-2018
- FDA event ID
- 79205
- Recalling firm
- Allen Medical Systems, Acton, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2017
- FDA classified
- 20 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 6 Oct 2017 | Recall initiated by company | |
| 20 Feb 2018 | Classified by FDA | +137 days |
| 28 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
The base of the frame has the potential to crack when the patient is initially transferred to the Bow Frame.
Which lots 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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 79205| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Allen Medical Bow Frame recalled | Allen Medical Systems | Device Malfunction | Nationwide |
More recalls from Allen Medical Systems
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | F-T3SYSTEM, T3 (Trumpf Table Top) System The device recalled | Allen Medical Systems | Other | Nationwide |
| Device | CLASS II | Allen Medical Bow Frame recalled | Allen Medical Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Arthrex Shoulder Suspension Tower recalled by Allen Medical Systems | Allen Medical Systems | Sterility | FL |
| Device | CLASS II | Arthex S3 Arm Sleeve Connector recalled by Allen Medical Systems | Allen Medical Systems | Device Malfunction | FL |
| Device | CLASS II | Allen Traction Boot, Modular recalled by Allen Medical Systems | Allen Medical Systems | Device Malfunction | 10 states |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |