10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion s

FDA device recall Z-2119-2017 · posted 2017-05-26 · Terminated

Recall details

Recalling firm

EBI Patient Care, Inc.

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LOE

Quantity affected

33 units total

Distribution

Nationwide distribution only.

Date initiated

2017-04-20

Date posted

2017-05-26

Date terminated

2018-10-17

Location

Guaynabo, PR