FDAJanuary 26, 2024device
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
in2bones sasin2bonesin2bones sas
UPCs
3760225710692
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPearl Milling Company Original Pancake & Waffle Mix Complete (Mezcla Para Panqueques y Waffles) Net Wt 5.99 oz (170 g). Packed in 50 - 5.99 oz BOPP Pouch units per master case. Keep in a cool, dry place.2026-05-13
- FDANeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 008179060...2026-05-11
- FDABrand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not ...2026-02-20
- FDAEPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutane...2025-05-23
- FDAAtalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabilitation institutions under the supervision of a trained operator.2025-04-03
- FDAThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. During the planning ...2024-08-05
- FDAI.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST1752024-01-26
- FDAHIGH V+ Spinal Cement System REF T040321K2022-12-15
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