CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

REF: P65 ST862 CoLag Screw, FT, 6.7X62.5 mm recalled by In2bones USA

In2bones USA is recalling REF: P65 ST862 CoLag Screw, FT, 6.7X62.5 mm, distributed nationwide in the US. The recall was initiated on 9 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 00817906023992/Lot: GM008380; GM007868

Quantity recalled29 units

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-0157-2027
FDA event ID: 99846
Recalling firm: In2bones USA, Cordova, TN
Classification: Class II
Status: Ongoing
Recall initiated: 9 Sep 2026
FDA classified: 14 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

9 Sep 2026	Recall initiated by company
14 Oct 2026	Classified by FDA	+35 days
21 Oct 2026	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

Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

Product as listed by the FDA

REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm

Where it was distributed

US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.

Nationwide Florida Georgia Hawaii North Carolina Ohio Pennsylvania South Dakota Texas Virginia

Questions about this recall

Why was it recalled?

Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.

Which lots are affected?

UDI: 00817906023992/Lot: GM008380; GM007868

Where was it sold?

US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.

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 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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