CLASS II Device recall · Reported 29 Sep 2021 · FDA Enforcement Report
CoLink Bone Graft Harvester, Sterile, Disposable recalled
In2bones USA is recalling CoLink Bone Graft Harvester, Sterile, Disposable, distributed nationwide in the US. The recall was initiated on 18 Aug 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2506-2021
- FDA event ID
- 88510
- Recalling firm
- In2bones USA, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Aug 2021
- FDA classified
- 22 Sep 2021
- Reported
- 29 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 18 Aug 2021 | Recall initiated by company | |
| 22 Sep 2021 | Classified by FDA | +35 days |
| 29 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaLouisianaMaineMichiganMinnesotaMissouriNorth CarolinaNebraskaNew JerseyNew Mexico
Questions about this recall
Why was it recalled?
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
Which lots are affected?
Lot Numbers: 992921, 1018971, 1046581, and 1070081.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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