I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

FDA Device Recall #Z-1320-2024 — Class II — January 26, 2024

Recall Summary

Recall Number Z-1320-2024
Classification Class II — Moderate risk
Date Initiated January 26, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm In2Bones, SAS
Location Ecully
Product Type Devices
Quantity 63 units

Product Description

I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180

Reason for Recall

This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.

Distribution Pattern

US Nationwide distribution in the state of Tennessee.

Lot / Code Information

UDI/DI 3760225710692, Batch Number 2306008, exp. 31/MAY/2028

Other Recalls from In2Bones, SAS

Recall # Classification Product Date
Z-1319-2024 Class II I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg ... Jan 26, 2024
Z-1283-2021 Class II In2Bones Shannon Percutaneous Burr - Product Us... Feb 9, 2021
Z-2869-2017 Class II Non-Locking screws in the following lengths: (... Jul 13, 2017
Z-0952-2017 Class II SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP... Dec 19, 2016
Z-0953-2017 Class II NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2... Dec 19, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.