LDR Spine Recalls ROI-A Anterior Delivery Device Due to Binding
LDR Spine USA is recalling 24 units of the ROI-A Anterior Delivery Device because the T-handle rotation has experienced binding. No patient injuries have been reported.
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 is classified as FDA Class II and involves a mechanical defect in a surgical instrument. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High (3).
Plain-English summary
LDR Spine USA, Inc. is recalling 24 units of the ROI-A Anterior Delivery Device, model number SI-ROIA-0023. This orthopedic manual surgical instrument is an auxiliary tool used in the ROI-A-ALIR cage system for spinal intervertebral body fusion. The recall is due to a defect where the T-handle rotation has experienced binding.
The affected units are identified by lot numbers 2295101A, 2295101A-R, and 2296101A-R. These devices were distributed in the United States to the states of Georgia, Oregon, Florida, Kentucky, North Carolina, Arkansas, and Pennsylvania.
The source text states that there have been no reports of patient injury. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023 Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device.
- Manufacturer
- LDR Spine USA, Inc.
- Hazard
- Affected units
- 24
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 (3)
- Lot # 2295101A
- 2295101A-R
- 2296101A-R
Distribution
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