Z-2506-2021Class II

CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 -

Name: Z-2506-2021 CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 -
Creator: In2bones USA, LLC
Published: 2021-08-18
License: https://open.fda.gov/license/

In2bones USA, LLC / initiated 2021-08-18 / Terminated / root cause: manufacturing process

FDA source

In2bones USA, LLC began a recall of CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the... on 2021-08-18. FDA classified it as Class II and gives the reason as "Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2506-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-18
Posted: 2021-09-22
Terminated: 2023-08-08
Recalling firm: In2bones USA, LLC
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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot Numbers: 992921, 1018971, 1046581, and 1070081.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2506-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2506-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)