Intervertebral fusion device recalled for outer carton labeling discrepancy
DePuy Spine's EIT CIF intervertebral fusion cage (46 units, Part No. CUI8070S) is recalled due to a labeling discrepancy where the outer carton label does not match the labels on the product packaging and patient materials.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling discrepancy on packaging with no reported illnesses or injuries. The issue is a documentation error rather than a product defect affecting device safety or performance.
Plain-English summary
The FDA is recalling the EIT CIF intervertebral fusion cage, H 7mm, 8-degree, S model (Part Number CUI8070S), manufactured by DePuy Spine, Inc. This intervertebral body fusion device is indicated for use with autograft as an adjunct to fusion in patients with cervical disc disease. Approximately 46 units were distributed nationwide.
The recall is due to a labeling discrepancy: the label on the outer carton does not match the labels on the outer blister package, inner blister package, and patient labels. The outer carton label may not be correct.
Patients who have received this device should contact their surgeon or healthcare provider with any questions about proper device identification and labeling.
The recalled product
- Product
- EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S
- Manufacturer
- DePuy Spine, Inc.
- Category
- Medical Device — Spinal Surgery
- Hazard
- label-discrepancy
- documentation-error
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)
- UDI-DI: 04260557770573 Lot Number: E20CL0637
Distribution
Distributed nationwide across the United States.
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