Z-2118-2017Class I

10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the...

Name: Z-2118-2017 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the...
Creator: EBI Patient Care, Inc.
Published: 2017-04-20
License: https://open.fda.gov/license/

EBI Patient Care, Inc. / initiated 2017-04-20 / Terminated

FDA source

EBI Patient Care, Inc. began a recall of 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 on 2017-04-20. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2118-2017
Classification: Class I
Status: Terminated
Initiated: 2017-04-20
Posted: 2017-05-26
Terminated: 2018-10-17
Recalling firm: EBI Patient Care, Inc.
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.
Product code: LOE Stimulator, Invasive Bone Growth
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 root cause: Other
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].
Quantity in commerce: 33 units total
Distribution: Nationwide distribution only.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2118-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2118-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-25
Z-2119-2017	Class I	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-25

Product code LOE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)