Z-2118-2017 Class I Terminated
FDA device recall Z-2118-2017 was initiated by EBI Patient Care, Inc. on April 20, 2017 and is designated Class I. 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… The recall status is terminated (terminated October 17, 2018). Affected quantity: 33 units total.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- April 20, 2017
- Termination Date
- October 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units total
Product Description
10-1335M - SpF-XL IIB 2/DM 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.
Distribution Pattern
Nationwide distribution only.
Code Information
Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667.