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Terminated

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.

FDA Recall Z-2506-2021 · Posted None

Recalling FirmIn2bones USA, LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2021-08-18
Date Terminated2023-08-08
Product Quantity835 units

Reason for Recall

Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

Firm 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.

Root Cause

Process change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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