Recall Z-2119-2017— EBI Patient Care, Inc.
Class I · Terminated
Class I FDA medical device recall by EBI Patient Care, Inc., initiated 2017-04-20, terminated 2018-10-17. FDA's recall record names no specific 510(k) clearance for this event. Product: 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.. Reason: Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product..
- Recalling firm
- EBI Patient Care, Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2017-04-20
- Terminated
- 2018-10-17
- Firm location
- Guaynabo, PR, United States
Product description
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Reason for recall
Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.