SpineFrontier Recalls Rev E PedFuse Return Screw Inserters Due to Loose Set Screw
SpineFrontier, Inc. is recalling eight Rev E PedFuse Return Screw Inserters because a set screw can loosen, causing the collar and locking sleeve to slide off the instrument.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that could compromise instrument stability during surgery. While no injuries are reported, the risk of harm during a surgical procedure places this in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
SpineFrontier, Inc. is recalling eight units of the Rev E PedFuse Return Screw Inserter, Part Number 11-80030. These instruments are used to capture, hold, and drive pedicle screw assemblies during spinal surgery. The specific units involved are from Lot Number PM3979 and were distributed only in Texas.
The recall is due to a defect where the set screw that fixes a collar to the inserter can loosen and fall out. When this happens, the collar can slide off the proximal end of the inserter, which may also allow the locking sleeve to slide off. This defect could compromise the stability of the instrument during use.
Healthcare providers who have these specific units should stop using them and contact SpineFrontier, Inc. for instructions on return or replacement. The recall is limited to the eight units identified by the specific lot number and distribution area.
The recalled product
- Product
- Rev E PedFuse Return Screw Inserter, Part Number: 11-80030 Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds the screw in place. There is also a feature used to lock the screw to the…
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: PM3979
Distribution
Distributed in 1 state:
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