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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 Stimulatorsee related information
Date Initiated by FirmApril 20, 2017
Date PostedMay 26, 2017
Recall Status1 Terminated 3 on October 17, 2018
Recall NumberZ-2118-2017
Recall Event ID 77089
PMA NumberP850035 P850035S031 
Product Classification Stimulator, invasive bone growth - Product Code LOE
Product10-1335M - 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		Other
ActionAn 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 Commerce33 units total
DistributionNationwide distribution only.
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LOE
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