The Recall Desk
HighFDA (Devices)·Z-1319-2024·Announced 2024-03-27

I.B.S. 6.5-C Compression Screw Batch Recalled for Dimensional Mix-Up

A batch of I.B.S compression screws may have incorrect dimensions compared to their labels due to a batch mix-up. The 59 affected units were distributed nationwide in Tennessee.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device (surgical implant requiring precise dimensions) with no reported injuries or illnesses to date. The FDA Class II classification and absence of reported harm limit the severity below Severe.

Plain-English summary

In2Bones, SAS is recalling a batch of I.B.S 6.5-C Compression screws (part number S65 ST175) following identification of a batch mix-up between two screw models with different lengths. The screws in this batch may have different lengths than indicated on their labels.

The recalled batch (number 2306007) consists of 59 units distributed nationwide in Tennessee. These compression screws are 6.5mm in diameter with dimensions that may not match their product labels.

If you have received these screws, verify their actual dimensions before use. Contact In2Bones, SAS for instructions on handling affected units and obtaining replacements.

The recalled product

Product
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175
Manufacturer
In2Bones, SAS
Category
Medical Device — Orthopedic Implants
Hazard
  • dimensional-mismatch
  • implant-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI 3760225710685
  • Batch Number 2306007
  • exp. 31/MAY/2028

Distribution

Distributed nationwide across the United States.

Related recalls

Same category