Home / Recalls / EBI Patient Care, Inc. / Z-2119-2017

Z-2119-2017 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

10-1398M - 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.

Distribution Pattern

Nationwide distribution only.

Code Information

Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.