Recall Z-0286-2019— Zimmer Biomet, Inc.
Class I · Terminated
Class I FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-02-19, terminated 2020-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.. Reason: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-02-19
- Terminated
- 2020-08-25
- Firm location
- Warsaw, IN, United States
Product description
EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
Reason for recall
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Data sourced from openFDA. This site is unofficial and independent of the FDA.