Recall Z-0157-2027 ยท HWC Screw, Fixation, Bone
In2bones USA, LLC
REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
| Date | Oct 14, 2026 (initiated Sep 9, 2026) |
| Status | Open, Classified |
| Reason | Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws. |
| 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 |
| Quantity | 29 units |
| Distribution | US Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170518 | In2Bones Fracture and Correction System In2bones USA, LLC, Jul 14, 2017 |