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IBS™ S65 ST175Recalls & reported problems

In2bones · IBS 6.5-C COMPRESSION SCREW, DIAM6.5 LG75 MM T25 · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K131920); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 26, 2024Open, Classified

    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.

    Z-1319-2024 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131920. One submission often covers many models, so check the product and lot details in each record.

  • Z-1320-2024 · Jan 26, 2024 · Open, Classified
    I.B.S 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180
  • Z-0397-2016 · Nov 18, 2015 · Terminated
    IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

Other Screw, Fixation, Bone devices

All Screw, Fixation, Bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.