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Terminated

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

FDA Recall Z-0070-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeKRO
Date Initiated2017-04-25
Date Terminated2018-02-06
Product Quantity1

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.

Firm Action

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

Root Cause

Nonconforming Material/Component

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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