FDA-Device2026-10-21Class IIMISBRANDING
In2bones USA CoLag bone screws recalled for labeling error—partially threaded sold as fully threaded
What this means
In2bones USA distributed CoLag bone screws labeled as fully threaded that are actually partially threaded. This mismatch could affect surgical outcomes if the wrong screw type is used during orthopedic procedures. The error affected 29 units distributed across multiple states.
- If you received or used these screws (UDI 00817906023992, Lot GM008380 or GM007868), contact In2bones USA or your distributor immediately.
- Do not use these screws in surgical procedures.
- Review any recent surgical records if these screws were implanted, and consult your surgeon.
The agency's original wording
Hazard
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Affected count
29 units
Manufactured in
7750a Trinity Rd, Cordova, TN, United States
Products
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0157-2027Want us to check the next one for you?
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