Z-0070-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2017
- Initiation Date
- April 25, 2017
- Termination Date
- February 6, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Reason for Recall
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.
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.
Code Information
Part Number: CP116574 Lot Number: 073840