Recall Z-2506-2021— In2bones USA, LLC
Class II · Terminated
Class II FDA medical device recall by In2bones USA, LLC, initiated 2021-08-18, terminated 2023-08-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site..
- Recalling firm
- In2bones USA, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-18
- Terminated
- 2023-08-08
- Firm location
- Memphis, TN, United States
Product description
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.
Reason for recall
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Data sourced from openFDA. This site is unofficial and independent of the FDA.