Zimmer Biomet, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0070-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 25, 2017

Date Posted: November 15, 2017

Recall Number: Z-0070-2018

Event ID: 78299

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.

Status: Terminated

Product Quantity: 1

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.

Voluntary or Mandated:

Voluntary: Firm initiated