Recall archive / FDA device enforcement
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180 — FDA record Z-1320-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- In2Bones, SAS
- Quantity
- 63 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1320-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 3760225710692, Batch Number 2306008, exp. 31/MAY/2028 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of Tennessee.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 27, 2024
- Recall initiation date
- Jan 26, 2024
- Center classification date
- Mar 20, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.