FDA Medical Device Recalls (openFDA)
EBI Patient Care, Inc.: 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
- Recall number
- Z-2119-2017
- Recalling firm
- EBI Patient Care, Inc.
- Product
- 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
- Status
- Terminated
- Initiated
- 2017-04-20
- Posted
- 2017-05-26
- Terminated
- 2018-10-17
- Reason
- 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.
- 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 corporatequality.postmarket@zimmerbiomet.com.
- Quantity
- 33 units total
- Distribution
- Nationwide distribution only.
- Lot, serial or model codes
- Serial Numbers: 410093 410094 410096 410103 410111 410115 410119 410148 410151 410158, and 410171.
- 510(k) numbers
- not on file
- PMA numbers
- ["P850035"]
- Product code
- LOE
- Firm FEI
- 3003435252
- Firm city
- Guaynabo
- Firm state
- PR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28