Device 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.
Z-2119-2017
Product summary
- Event
- Event 77089
- Status
- Terminated
- Classification
- Class I
- Quantity
- 33 units total
- Official record key
device-enforcement:Z-2119-2017
Official wording
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.
Code information: Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
Distribution pattern: Nationwide distribution only.
Derived failure modes
-
Unknown
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.