| Class 2 Device Recall CoLink Bone Graft Harvester | |
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
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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.
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Recalling Firm/ Manufacturer |
In2bones USA, LLC 6000 Poplar Ave Ste 115 Memphis TN 38119-3981
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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 |
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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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