10-1398M - SpF-PLUS Implantable Stimulator recallZ-2119-2017 · EBI Patient Care, Inc. · initiated Apr 20, 2017
Class I Terminated All recalls posted in May 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from EBI Patient Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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].
Recall details
- Recall number
- Z-2119-2017
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Apr 20, 2017
- Posted by the FDA
- May 26, 2017
- Recalling firm
- EBI Patient Care, Inc.
- Quantity
- 33 units total
- Product code
- LOE
- FDA submissions
- P850035
- Distribution
- Nationwide distribution only.
Product description
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
Code information (models, lots, serial numbers)
Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
Other devices under the same FDA submission
3 devices cleared under P850035 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SpF XL IIb Implantable Spinal Fusion Stimulator 10-1335MEbi, LLC · Stimulator, Invasive Bone Growth7 reports
- SpF®-PLUS-Mini (60 uA/M) 10-1398MEbi, LLC · Stimulator, Invasive Bone Growth7 reports
- SpF®-XL IIb Implantable Spinal Fusion Stimulator 10-1335WEbi, LLC · Stimulator, Invasive Bone Growth1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 77089).
- Z-2118-2017 · Terminated10-1335M - 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.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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