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U.S. Department of Health and Human Services

Class 1 Device Recall SpFXL IIB 2/DM Implantable Stimulator

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  Class 1 Device Recall SpFXL IIB 2/DM Implantable Stimulator see related information
Date Initiated by Firm April 20, 2017
Create Date May 26, 2017
Recall Status1 Open3, Classified
Recall Number Z-2118-2017
Recall Event ID 77089
PMA Number P850035 P850035S031 
Product Classification Stimulator, invasive bone growth - Product Code LOE
Product 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.
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.
Recalling Firm/
Manufacturer
EBI Patient Care, Inc.
484 Calle E
Guaynabo PR 00969-3454
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
Action An Urgent Medical Device Recall letter, dated April 20, 2017, was sent to the firm's consignees. The letter identified the affected product and the reason for the recall, as well as the risks involved. Consignees were instructed to quarantine affected product in their inventory and complete the Certification of Acknowledgement portion and the Inventory Return Certification Form in the letter. Affected product must be returned immediately along with the completed Inventory Return Certification Form. Questions or concerns should be directed to the customer call center at 1-800-447-3625 or via email to corporatequality.postmarket@zimmerbiomet.com.
Quantity in Commerce 33 units total
Distribution Nationwide distribution only.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LOE and Original Applicant = EBI, LLC
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