Home / Recalls / EBI Patient Care, Inc. / Z-2118-2017

Z-2118-2017 Class I Terminated

Recalled by EBI Patient Care, Inc. — Guaynabo, PR

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.