Data Foundry

Medical device recalls 2021

CoLink Bone Graft Harvester — Class II medical device recall Z-2506-2021

Terminated recall by In2bones USA, LLC, reported 2021-09-29, distributed nationwide. Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.

Recall numberZ-2506-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIn2bones USA, LLC, Memphis, TN, United States
Recall initiated2021-08-18
Classified2021-09-22
Reported by FDA2021-09-29
Terminated2023-08-08
DistributedNationwide (US)
Quantity835 units
Lot numbers1018971, 1046581, 1070081, 992921
Model numbersG05, S1008

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 for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2506-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.