Recall Z-0287-2019— 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: SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. 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
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
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.