Recall Z-0157-2027— In2bones USA, LLC

Name: FDA recall Z-0157-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-09

Class II · Ongoing

Class II FDA medical device recall by In2bones USA, LLC, initiated 2026-09-09. It names one FDA 510(k) clearance: K170518. Product: REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm. Reason: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws..

Recalling firm: In2bones USA, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-09-09
Firm location: Cordova, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K170518 — In2Bones Fracture and Correction SystemIn2bones USA, LLC·cleared 2017-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.