Synthes Graphic Case F/7.3mm Cannulated Screw Set Recalled for Measurement Error
Synthes (USA) Products LLC is recalling three units of the Graphic Case F/7.3mm Cannulated Screw Set because the included gauges measure screws 5.41mm shorter than their actual length.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a measurement defect that poses a risk of harm during surgical procedures, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Synthes (USA) Products LLC is recalling three units of the Graphic Case F/7.3mm Cannulated Screw Set, part number 690.380. The recall is due to a defect in the included screw gauges, which incorrectly measure screws as 5.41mm shorter than the actual overall screw length.
The affected units were distributed to accounts in California, Illinois, Indiana, Kansas, Louisiana, Maryland, North Carolina, Nebraska, New Jersey, Oregon, Texas, and Virginia, as well as to Canada. The specific code for the affected units is H340372.
Healthcare providers and consumers should stop using the affected screw gauges immediately. Users should contact Synthes (USA) Products LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Part no. 690.380, Graphic Case F/7.3mm Cannulated Screw Set
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 3
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)
- H340372
Distribution
Part of a larger recall action
This product is one of 3 recalled by Synthes (USA) Products LLC 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.
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