Reported Jun 12, 2019 · Terminated
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel…
OMNIlife science Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OMNIlife science Inc. · 480 Paramount Dr · Raynham, MA · 02767-1085
Is this the product you have?
- OMNIBotics iBlock Cutting Guide, 4146-1000 -
- Product UsageThe OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System
- Lot codes and dates
- MI1218
- Amount recalled
- 9
Where it was sold
Why it was recalled
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.
This product could cause temporary or reversible health problems — stop using it.
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