EIT CIF Cage Intervertebral Fusion Device Carton Labeling Mismatch Recall
DePuy Spine is recalling 61 units of the EIT CIF cage spinal fusion device due to a labeling mismatch. The outer carton label does not match the labels on the blister packages and patient information labels.
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 2/5 (Moderate).
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: FDA Class II medical device recall involving a labeling mismatch with no reported illnesses or injuries. This qualifies as a minor labeling error per the severity rubric.
Plain-English summary
DePuy Spine, Inc. is recalling 61 units of the EIT CIF cage intervertebral body fusion device (Part Number CUI8060L, Lot Number E20CL0603) distributed nationwide in the United States. The device is indicated for use with autograft as an adjunct to fusion in patients with cervical disc disease.
The recall was issued because 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 contains information that may not be correct, while the labels on the other packaging are correct.
No illnesses or injuries have been reported to date. Patients or healthcare providers who have this device should verify the correct labeling on the actual device packaging and contact DePuy Spine, Inc. with any concerns.
The recalled product
- Product
- EIT CIF cage, H 6mm, 8degree, L- 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: CUI8060L
- Manufacturer
- DePuy Spine, Inc.
- Category
- Medical Device — Spinal implant
- Hazard
- Affected units
- 61
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: 04260557770658 Lot Number: E20CL0603
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by DePuy Spine, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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