Medical Device Recall: Orthopedic Compression Screws with Incorrect Dimensions
In2Bones, SAS is recalling I.B.S Compression screws due to a batch mix-up. Affected screws may have different lengths than indicated on their labels, creating a risk of improper surgical implantation.
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: FDA Class II recall for a medical device with dimensional mismatch on an orthopedic surgical implant. No injuries or illnesses reported in the source. Per the rubric, this constitutes a risk-of-harm medical device where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
In2Bones, SAS is recalling I.B.S Compression screws (6.5mm diameter) due to a batch mix-up that resulted in incorrect product being distributed. Affected units may contain 75mm-length screws mislabeled as 80mm-length screws, or vice versa. The recall affects 63 units distributed nationwide in Tennessee. The affected batch (Batch Number 2306008, UDI/DI 3760225710692) has an expiration date of May 31, 2028.
Compression screws are orthopedic implants used in surgical procedures to provide fixation and support. A dimensional mismatch between the actual product and the label could result in the wrong implant being used during surgery, potentially compromising the surgical repair and patient safety.
Consumers and healthcare providers should immediately stop using the recalled units. Healthcare facilities should quarantine the affected batch and review patient records to identify whether any of these screws were already implanted. Patients who may have received these screws during surgery should contact their healthcare provider to determine if follow-up care is needed.
For more information, patients and providers may contact In2Bones, SAS or consult the FDA recall notice at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-1320-2024.
The recalled product
- Product
- I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
- Manufacturer
- In2Bones, SAS
- Hazard
- batch-mix-up
- dimension-mismatch
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 3760225710692
- Batch Number 2306008
- exp. 31/MAY/2028
Distribution
Distributed nationwide across the United States.
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