Instratek Recalls Mini Screw Sets with Faded Markings
Instratek is recalling 96 Mini Screw Sets and gauges due to faded and incorrect markings on instruments.
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, but the hazard is limited to faded and wrong markings on instruments, which constitutes a minor labeling error without reported injuries.
Plain-English summary
Instratek, Incorporated is recalling 96 units of the Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges. The recall is due to faded and wrong markings on the bone screw Countersink/Depth Gauge instruments in the Mini Screw Set.
The affected products include Mini System part no. IS1100 (lots 0001-0047) and Instrument part nos. IS1103, IS1104, and IS1105 (lots 918101, 918102, and 918103). These products were distributed nationwide to facilities in Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, and Colorado.
The FDA has classified this as a Class II recall. Healthcare providers should stop using the affected instruments and contact Instratek for instructions on return or replacement.
The recalled product
- Product
- Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
- Manufacturer
- Instratek, Incorporated
- Hazard
- Affected units
- 96
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 (6)
- Mini System part no. IS1100 - lot 0001-0047
- Instrument part nos. IS1103
- IS1104
- and IS1105 - lots 918101
- 918102
- and 918103
Distribution
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