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.
FDA Recall Z-2118-2017 · Posted 2017-05-26
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Recalling FirmEBI Patient Care, Inc.
Recall StatusTerminated
Product CodeLOE
Date Initiated2017-04-20
Date Terminated2018-10-17
Product Quantity33 units total
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.
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 [email protected].
Root Cause
Other
Distribution Pattern
Nationwide distribution only.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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