CoLag recallZ-0157-2027 · In2bones USA, LLC · initiated Sep 9, 2026
Open, Classified All recalls posted in October 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from In2bones USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
FDA root cause category: Error in labeling
What the company is doing
On September 9, 2026, In2Bones, a CONMED Corporation, issued a Urgent: Medical Device Recall Notification via email. In2Bones ask consignees to take the following actions: 1. Please review, immediately identify and quarantine all affected devices within your facility. Discontinue use and distribution of affected devices. 2. Share this notice with all departments within your facility and all other facilities that may have received affected products from you. 3. Please complete the medical device recall response form and return it with the devices to: CONMED Corporation, RGA#: RGA-RA-CS-XXX,7750A Trinity Road, Cordova, TN 38018, Attn: Cameron Ealy, Return via: UPS Account #: 9A0303 (no charge to your facility) 3a. If you DO NOT HAVE any affected devices to return, please complete the medical device recall response form, indicating you have no devices and return by email to: [email protected] 4. Please do not return open or used devices.
Recall details
- Recall number
- Z-0157-2027
- Recall class
- Not yet classified by the FDA
- Status
- Open, Classified
- Initiated by the company
- Sep 9, 2026
- Posted by the FDA
- Oct 14, 2026
- Recalling firm
- In2bones USA, LLC
- Quantity
- 29 units
- Product code
- HWC
- FDA submissions
- K170518
- Distribution
- US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Product description
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Code information (models, lots, serial numbers)
UDI: 00817906023992/Lot: GM008380; GM007868
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CoLag™ P65 ST862In2Bones USA, LLC · Screw, Fixation, Bone1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K170518 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CoLag P06 S0004In2Bones USA, LLC · Orthopedic manual surgical instrument2 reports
- 5MS P06 S0021In2Bones USA, LLC · DRIVER, PROSTHESIS1 report
- 5MS™ P60 ST032In2Bones USA, LLC · Screw, Fixation, Bone1 report
- 5MS™ P62 ST416In2Bones USA, LLC · Screw, Fixation, Bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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