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Recall Observatory FDA recall evidence

Device product

Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

Z-0070-2018

April 25, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 78299
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0070-2018

Official wording

Reason: 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.

Code information: Part Number: CP116574 Lot Number: 073840

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.