Recall Z-0070-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-04-25, terminated 2018-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.. 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..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-25
- Terminated
- 2018-02-06
- Firm location
- Warsaw, IN, United States
Product description
Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.