—#159084

Product

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

FDA product code: KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Part Number: CP116574 Lot Number: 073840

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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.

Timeline

Recall initiated: 2017-04-25
Terminated: 2018-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159084. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.