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U.S. Department of Health and Human Services

Class 2 Device Recall CoLag SCREW, FT, Dia. 6.7X62.5 mm

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 Class 2 Device Recall CoLag SCREW, FT, Dia. 6.7X62.5 mmsee related information
Date Initiated by FirmSeptember 09, 2026
Date PostedOctober 14, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0157-2027
Recall Event ID 99846
510(K)NumberK170518 
Product Classification Screw, fixation, bone - Product Code HWC
ProductREF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mm
Code Information UDI: 00817906023992/Lot: GM008380; GM007868
FEI Number 3011580264
Recalling Firm/
Manufacturer		 In2bones USA, LLC
7750a Trinity Rd
Cordova TN 38018-2722
For Additional Information ContactField Action Support Team
844-602-6637
Manufacturer Reason
for Recall		Due to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.
FDA Determined
Cause 2		Error in labeling
ActionOn 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: colag2026@conmed.com 4. Please do not return open or used devices.
Quantity in Commerce29 units
DistributionUS Nationwide distribution in the states of FL, GA, HI, NC, OH, PA, SD, TX, VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HWC
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