Synthes Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set Recalled
Synthes (USA) Products LLC is recalling 7 units of a combined cannulated screw set because the included gauges measure screws 5.41mm shorter than 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 defect that could lead to incorrect surgical measurements, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Synthes (USA) Products LLC is recalling 7 units of Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set. The recall is due to a defect in the affected screw gauges, which incorrectly measure screws 5.41mm shorter than the actual overall screw 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 consumers should stop using the affected screw gauges immediately and contact Synthes (USA) Products LLC for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Part no. 690.375, Graphic Case F/6.5mm & 7.3mm Combined Cannulated Screw Set
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 7
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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