FDA Medical Device Recalls (openFDA)
In2bones USA, LLC: 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.
- Recall number
- Z-2506-2021
- 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.
- Status
- Terminated
- Initiated
- 2021-08-18
- Posted
- not on file
- Terminated
- 2023-08-08
- Reason
- Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 992921, 1018971, 1046581, and 1070081.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3011580264
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28