Integra Recalls TS Series Depth Gauges for Incorrect Markings
Integra LifeSciences is recalling 71 TS Series Depth Gauges because some units exceed length specifications or have incorrect millimeter markings.
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 source text describes a manufacturing non-conformance regarding dimensions and markings without reporting any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 71 units of the TS Series Depth Gauge for the Integra Ti6 Internal Fixation System. These gauges are used by physicians to determine the correct screw length when implanting 2.0 or 2.5mm TS Series screws.
The recall was initiated following an internal investigation into a non-conformance. The investigation determined that depth gauges from Lot UP15H2 exceed overall length specification requirements. Additionally, depth gauges from prior lot numbers UP09D3 and UP07E2, manufactured before Integra acquired the product line, reflect an incorrect number for the first millimeter depth marking; the marking displays '6' instead of the correct '4'.
The affected units were distributed in the United States to the states of Colorado, Florida, Illinois, Michigan, New Jersey, New York, South Carolina, Texas, and Virginia. Consumers and healthcare providers should stop using these specific depth gauges and contact the manufacturer for further instructions.
The recalled product
- Product
- TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 71
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 UP15H2
- Lot UP09D3
- Lot UP07E2
Distribution
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