CLASS II ONGOING Device recall · Reported 27 Mar 2024 · FDA Enforcement Report
I.B.S¿ 5-C Compression screw - diam lg recalled by In2Bones, SAS
In2Bones, SAS is recalling I.B.S¿ 5-C Compression screw - diam lg, distributed nationwide in the US. The recall was initiated on 26 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1320-2024
- FDA event ID
- 94063
- Recalling firm
- In2Bones, SAS, Ecully
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Jan 2024
- FDA classified
- 20 Mar 2024
- Reported
- 27 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 26 Jan 2024 | Recall initiated by company | |
| 20 Mar 2024 | Classified by FDA | +54 days |
| 27 Mar 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
Where it was distributed
US Nationwide distribution in the state of Tennessee.
Questions about this recall
Is I.B.S¿ 5-C Compression screw - diam lg recalled?
Yes. In2Bones, SAS recalled I.B.S¿ 5-C Compression screw - diam lg on 26 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1320-2024.
Why was it recalled?
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.
Which lots are affected?
UDI/DI 3760225710692, Batch Number 2306008, exp. 31/MAY/2028
Where was it sold?
US Nationwide distribution in the state of Tennessee.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from In2Bones, SAS
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | I.B.S¿ 5-C Compression screw - diam lg recalled by In2Bones, SAS | In2Bones, SAS | Packaging Defects | Nationwide |
| Device | CLASS II | In2Bones Shannon Percutaneous Burr recalled by In2Bones, SAS | In2Bones, SAS | Device Malfunction | Nationwide |
| Device | CLASS II | Non-Locking screws in the following lengths: (a) NEO(R) recalled | In2Bones, SAS | Device Malfunction | TN |
| Device | CLASS II | Neoview(r) Screws Set recalled by In2Bones, SAS | In2Bones, SAS | Sterility | Nationwide |
| Device | CLASS II | Neo Screw 7- Locking recalled by In2Bones, SAS | In2Bones, SAS | Other | Nationwide |
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