Z-0070-2018Class II

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

Name: Z-0070-2018 Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace...
Creator: Zimmer Biomet, Inc.
Published: 2017-04-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-04-25 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy on 2017-04-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0070-2018
Classification: Class II
Status: Terminated
Initiated: 2017-04-25
Posted: 2017-11-08
Terminated: 2018-02-06
Recalling firm: Zimmer GmbH
Product: Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.
Quantity in commerce: 1
Distribution: 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.
Product codes and lots: Part Number: CP116574 Lot Number: 073840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0070-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0070-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-15	2017-11-08

Product code KRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)