FDA Medical devices recall ·
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm recall
- Recall number
- Z-0157-2027
- Date
- (initiated September 9, 2026)
- Company / brand
- In2bones USA, LLC
7750a Trinity Rd, Cordova, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29 units
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Why was it recalled?
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 00817906023992/Lot: GM008380; GM007868
Distribution
US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
States: Florida Georgia Hawaii North Carolina Ohio Pennsylvania South Dakota Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0157-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.