In2bones recalls CoLink Bone Graft Harvesters that may break at the outer tube weld site, causing potential injury during surgery. Affected models include REF G05 S1008 with specific lot numbers.
Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.
In2bones is recalling CoLink Bone Graft Harvesters that have broken at the outer tube weld site. This could lead to injury during surgical procedures if the device fails unexpectedly.
The device may break at the outer tube weld site during use, which could cause injury to the surgical team or compromise the procedure. This breakage is reported in complaints but does not indicate a risk of death or serious injury in normal use.
Surgeons and medical professionals who use the CoLink Bone Graft Harvester during surgical procedures are most at risk. The recall affects specific lot numbers of the 8mm sterile disposable device.
Check the product label for the model REF G05 S1008 and lot numbers 992921, 1018971, 1046581, or 1070081. The device is a sterile, disposable instrument used by surgeons during bone procedures.
Look for the model number REF G05 S1008 and lot numbers 992921, 1018971, 1046581, or 1070081 on the product.
The recall is due to complaints that CoLink Bone Graft Harvesters break at the outer tube weld site, which could cause injury during surgical procedures.
The official recall notice does not specify a remedy, so you should check with In2bones USA, LLC for further instructions.
The recall reports complaints of breakage but does not state that the device can cause death or serious injury in normal use.
We’ve drafted a message you can send In2bones to request your refund or repair — edit it as you like.
Subject: Recall Z-2506-2021 — In2bones In2bones Hello, I own a In2bones that is covered by recall Z-2506-2021 from In2bones. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.