SpineFrontier Recalls Surgical Case Lids and Bases Due to Ink Delamination
SpineFrontier, Inc. is recalling specific surgical case lids and bases because non-toxic inks used on the graphics are delaminating or running off after repeated washing and sterilization cycles.
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: The recall is classified as FDA Class II, and the hazard involves ink delamination from a medical device. Since the source text does not report any illnesses or injuries, and the inks are described as non-toxic, this fits the criteria for a moderate severity recall involving a potential but unreported risk.
Plain-English summary
SpineFrontier, Inc. is recalling specific surgical case lids and bases, including Inspan, Invue, S-Lift, Arena-C, and Generics models. The recall involves 258 units, with 30 units in distribution at the time of the recall. These system cases are designed to hold and secure instrumentation used with surgical systems.
The recall was initiated because non-toxic inks used on the silk screen graphics of the case bases, lids, and caddy lids were found to be delaminating or running off from the substrate after repeated washing and sterilization cycles. The affected products were distributed worldwide, including in the United States (Florida, Ohio, Massachusetts, and Texas), Mexico, and the Dominican Republic.
Healthcare facilities and distributors should stop using the affected products and contact SpineFrontier, Inc. for instructions on how to return or dispose of the units. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D…
- Manufacturer
- SpineFrontier, Inc.
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 (20)
- Inspan Lid: Part Number: 12-60039A
- 11-60042B
- 11-60043B
- 11-60045B
- 11-60046C
- 11-60045A
- 11-60046A
- 11-60053A
- Lot Numbers: 7197.024
- 011649
- 011498
- Invue Lid: SI70095A
- Lot Number: 6250.009-R
- S-Lift Lid: SI50070A
- Lot Number: 7201.008
- S-Lift Base: SI50067A
- Lot Numbers: 7183.007R
- 7201.007
- Arena-C Lid: 11-72013D
- 11-72014D
Distribution
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