Use cautionMedical device recall · FDA · Published September 9, 2026
In2bones Bone Screws Recall: Partially Threaded Screws Risk Injury
In2bones USA recalls 29 partially threaded bone screws (model P65 ST862) sold nationwide. Due to labeling error, screws are not fully threaded and may cause injury during surgery.
“In2bones Bone Screws Recall: Partially Threaded Screws Risk Injury.” GovInfoNow, updated October 27, 2026. https://govinfonow.com/recall/1764691-in2bones-usa-llc-recalls-ref-p65-st862-colag-screw-ft. Based on FDA recall #Z-0157-2027 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0157-2027%22&limit=1).
In2bones USA, LLC voluntarily recalled bone screws due to a labeling error that caused fully threaded screws to be partially threaded instead, the FDA said on Sept. 9, 2026.
How to tell if you have it
Brand: In2bones
Product: Bone Screws
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
UDI: 00817906023992
Lot codes: GM008380, GM007868
Quantity: 29 units
The hazard
The bone screws specified as fully threaded are actually partially threaded due to a labeling error. The FDA classified this Class II recall as ongoing.
Context
GovInfoNow's records show In2bones USA, LLC has four other recalls on record since July 16, 2018. Other recent recalls of similar products include Synthes 2.4V TAP CORTEX SCREW Recall (Feb. 25, 2026), Smith & Nephew BIOSURE HA Screw Recall (Nov. 24, 2025), and Charlotte Claw Screw Recall (Aug. 18, 2026).
How to tell if you have this one
Check for the model number P65 ST862 on the packaging. The screws have a UDI of 00817906023992 and lot number GM008380 or GM007868.
Brand
In2bones
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model number P65 ST862 and UDI 00817906023992 with lot numbers GM008380 or GM007868.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Hawaii, North Carolina, Ohio, Pennsylvania, South Dakota, Texas, Virginia.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0157-2027 (September 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0157-2027 to see it in context.
Plain-language summary written by qwen3:4b on October 27, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.