Synthes Graphic Case F/6.5mm Cannulated Screw Set Recalled for Measurement Error
Synthes (USA) Products LLC is recalling four units of the Graphic Case F/6.5mm Cannulated Screw Set because the screw gauges measure 5.41mm shorter than the actual screw 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 to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling four units of the Graphic Case F/6.5mm Cannulated Screw Set, part number 690.379. The recall is due to a defect in the screw gauges included in the set, which incorrectly measure screws as 5.41mm shorter than their actual overall length.
The affected products 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 FL00860.
Healthcare providers and facilities should stop using the affected screw gauges and contact Synthes (USA) Products LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 4
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)
- FL00860
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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