Allen Medical Systems Recalls Radiolucent Surgery Spine Frames
Allen Medical Systems is recalling 161 Radiolucent Surgery Spine Frames because the base may crack during patient transfer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a structural defect in a medical device used for patient positioning, which falls under the 'structural vehicle defect' or 'significant injury' criteria for a Severe rating, despite the agency's Class II classification.
Plain-English summary
Allen Medical Systems is recalling 161 units of the Radiolucent Surgery Spine Frame (F70801). This surgical platform is used to position patients for lumbar spine procedures.
The recall is being issued because the base of the frame has the potential to crack when a patient is initially transferred to the Bow Frame. The affected units were distributed worldwide, including in the United States, Australia, Canada, and numerous other countries.
Healthcare facilities should stop using the affected devices and contact Allen Medical Systems for further instructions. The specific serial numbers for the recalled units are listed in the official recall documentation.
The recalled product
- Product
- Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position patients for lumbar spine procedures.
- Manufacturer
- Allen Medical Systems
- Affected units
- 161
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Allen Medical Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Allen Medical Systems
See all →- SevereAllen Medical Systems Recalls F-T3SYSTEM Surgical Table Accessories
FDA (Devices) · 2018-04-04
- SevereAllen Medical Bow Frame Recalled Due to Potential Base Cracking
FDA (Devices) · 2018-02-28
Same hazard · structural failure
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