Z-0157-2027

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

Name: Z-0157-2027 REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Creator: In2bones USA, LLC
Published: 2026-09-09
License: https://open.fda.gov/license/

In2bones USA, LLC / initiated 2026-09-09 / Open, Classified

FDA source

Recall record

Recall number: Z-0157-2027
Status: Open, Classified
Initiated: 2026-09-09
Posted: 2026-10-14
Recalling firm: In2bones USA, LLC
Product: REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Product code: HWC Screw, Fixation, Bone
Reason for recall: Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
FDA root cause: Error in labeling
Action: 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.
Quantity in commerce: 29 units
Distribution: US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Product codes and lots: UDI: 00817906023992/Lot: GM008380; GM007868

Product code HWC

K170518Class IIIn2Bones Fracture and Correction SystemIn2bones USA, LLC / cleared 2017-07-14

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-16. View this recall on fda.gov (opens on fda.gov)