SpineFrontier Recalls PedFuse Screw Caddies Due to Misaligned Screw Compartments
SpineFrontier, Inc. is recalling 11 PedFuse Screw Caddies because the compartments for 8mm and 9mm screws were switched, creating a risk of using the wrong screw size during spinal surgery.
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: This is a Class II recall involving a medical device where a defect could lead to the use of the wrong implant size during surgery, representing a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
SpineFrontier, Inc. is recalling 11 units of the PedFuse Screw Caddy, Part Number 11-80009 Rev. B. These caddies are used to organize 8mm and 9mm pedicle screws during the implantation of spinal stabilization devices for skeletally mature patients.
The recall was initiated because the two sections designated for the 8mm and 9mm screws were switched. Specifically, the holes designed to hold 8mm screws are actually designed for 9mm screws, and the holes designated for 9mm screws are designed for 8mm screws. This misalignment could lead to the selection of an incorrect screw size during surgery.
The affected caddies were distributed in the United States to the states of Colorado, the District of Columbia, Massachusetts, and Texas. Healthcare facilities and distributors should stop using these caddies and contact SpineFrontier, Inc. for instructions on how to return the product.
The recalled product
- Product
- Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of…
- Manufacturer
- SpineFrontier, Inc.
- Affected units
- 11
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 (4)
- 31176
- 018652
- 018645R
- 42011
Distribution
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