Alliance Partners Recalls Nakoma-SL Cervical Plating Drill Guides
Alliance Partners LLC is recalling 21 Nakoma-SL Anterior Cervical Plating System drill guides because screws may advance through the plate during implantation.
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 is classified as FDA Class II, and the defect involves a structural failure of a spinal implant that could lead to significant injury during surgery, meeting the criteria for a Severe rating.
Plain-English summary
Alliance Partners LLC is recalling 21 units of the Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide. The affected units are identified by lot numbers SM59161 and SM60278. These products were distributed nationwide in the states of Louisiana, Texas, and Puerto Rico.
The recall was issued due to a design issue where inadequate interference between the screw and the plate can occur when the screw is implanted at an angulation greater than 7 degrees. This defect can result in the screw advancing through the plate during the implantation process.
The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. It is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with conditions such as degenerative disk disease, trauma, tumors, deformities, pseudoarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis. Healthcare providers should contact Alliance Partners LLC for instructions on how to return or replace the affected devices.
The recalled product
- Product
- Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary…
- Manufacturer
- Alliance Partners LLC
- Affected units
- 21
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 numbers SM59161 and SM60278
Distribution
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