I.B.S. 6.5-C Compression Screw Batch Recalled for Dimensional Mix-Up
A batch of I.B.S compression screws may have incorrect dimensions compared to their labels due to a batch mix-up. The 59 affected units were distributed nationwide in Tennessee.
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: This is a risk-of-harm medical device (surgical implant requiring precise dimensions) with no reported injuries or illnesses to date. The FDA Class II classification and absence of reported harm limit the severity below Severe.
Plain-English summary
In2Bones, SAS is recalling a batch of I.B.S 6.5-C Compression screws (part number S65 ST175) following identification of a batch mix-up between two screw models with different lengths. The screws in this batch may have different lengths than indicated on their labels.
The recalled batch (number 2306007) consists of 59 units distributed nationwide in Tennessee. These compression screws are 6.5mm in diameter with dimensions that may not match their product labels.
If you have received these screws, verify their actual dimensions before use. Contact In2Bones, SAS for instructions on handling affected units and obtaining replacements.
The recalled product
- Product
- I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
- Manufacturer
- In2Bones, SAS
- Affected units
- 59
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)
- UDI/DI 3760225710685
- Batch Number 2306007
- exp. 31/MAY/2028
Distribution
Part of a larger recall action
This product is one of 2 recalled by In2Bones, SAS 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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