FDA-Device2017-11-15Class II
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Zimmer Biomet, Inc.
Hazard
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
Sold states
This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
Affected count
1
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0070-2018Don't want to check this manually?
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