Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
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.
What You Should Do
Remedy
The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.
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Products
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee.
This Rotating Hinged Knee is intended to replace patient anatomy.
- Brand
- Zimmer Biomet, Inc.
- UPC
- Part Number: CP116574 Lot Number: 073840
Units Affected
1