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U.S. Department of Health and Human Services

Class 2 Device Recall CoLink Bone Graft Harvester

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  Class 2 Device Recall CoLink Bone Graft Harvester see related information
Date Initiated by Firm August 18, 2021
Create Date September 22, 2021
Recall Status1 Terminated 3 on August 08, 2023
Recall Number Z-2506-2021
Recall Event ID 88510
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.
Code Information Lot Numbers: 992921, 1018971, 1046581, and 1070081.
Recalling Firm/
Manufacturer		 In2bones USA, LLC
6000 Poplar Ave Ste 115
Memphis TN 38119-3981
For Additional Information Contact Mr. Alan Taylor
901-849-0458
Manufacturer Reason
for Recall		 Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
FDA Determined
Cause 2		 Process change control
Action The recall letter dated 8/17/2021 was issued by the recalling firm via FedEx on 8/18/2021. It explains the description of the issue, associated risks, and requests the letter recipient to distribute the recall notice to all relevant persons within their organization. The consignee is to identify and quarantine the affected product for return to the firm.
Quantity in Commerce 835 units
Distribution US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, LA, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, VA, and WI. There was no military/government distribution.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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