SpineFrontier recalls A-CIFT SoloFuse Fixed Angle Driver Model 13-32101-01 (Lot EC20) due to potential binding when advancing intervertebral body fixation screws. Affected users should contact SpineFrontier for details.
There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw.
SpineFrontier is recalling a specific spinal surgery driver model because it may bind when advancing screws during spinal fusion procedures. This could lead to complications in surgery if not properly addressed.
The driver may bind when advancing the intervertebral body fixation screw, which could cause complications during spinal fusion surgery. This binding might lead to improper screw placement or surgical delays.
Spine surgery patients using the A-CIFT SoloFuse Fixed Angle Driver Model 13-32101-01 (Lot EC20) are most at risk. Surgeons and medical facilities that use this device may also be affected.
Check for the model number 13-32101-01 on the driver, along with component part numbers 14-32107-01 and 14-32106. The recall applies to Lot EC20 units sold for spinal surgery procedures.
Reach out to SpineFrontier directly for specific instructions on handling the recalled device.
The recall states there is a potential for the driver to bind when advancing screws, which could lead to complications during spinal fusion procedures.
Check for model number 13-32101-01 and component part numbers 14-32107-01 and 14-32106 on the device, and verify it was sold in Lot EC20.
Contact SpineFrontier directly for specific instructions on handling the recalled device.
We’ve drafted a message you can send SpineFrontier to request your refund or repair — edit it as you like.
Subject: Recall Z-1973-2019 — SpineFrontier SpineFrontier Hello, I own a SpineFrontier that is covered by recall Z-1973-2019 from SpineFrontier. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
