CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended f
Summary
The FDA issued a Class II for CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product U by In2bones USA, LLC. Reason: Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site..
Details
Source
Device Recall
External ID
Z-2506-2021
Action Date
2021-09-29
Status
Terminated
Category
device
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.
Lot/Code Info: Lot Numbers: 992921, 1018971, 1046581, and 1070081.
Quantity Affected: 835 units
Reason for Recall
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-18
Company
Memphis, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
In2bones USA, LLC has 10 FDA actions in our database, including 2 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (In2bones USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does In2bones USA, LLC have FDA actions?
In2bones USA, LLC has 10 FDA actions in our database, including 2 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2506-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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