FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
- Recall number
- Z-0070-2018
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
- Status
- Terminated
- Initiated
- 2017-04-25
- Posted
- not on file
- Terminated
- 2018-02-06
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Part Number: CP116574 Lot Number: 073840
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28