EBI Patient Care, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2118-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: April 20, 2017

Date Posted: May 31, 2017

Recall Number: Z-2118-2017

Event ID: 77089

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.

Status: Terminated

Product Quantity: 33 units total

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.

Distribution Pattern:

Nationwide distribution only.

Voluntary or Mandated:

Voluntary: Firm initiated