Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported May 31, 2017
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
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 cytotoxicit…
Ebi Patient Care, Inc. recalled 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to in… - a critical-severity action.
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to in… was recalled by Ebi Patient Care, Inc. in May 31, 2017. Reason: Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Sp…. Check the official notice for the remedy. Verify recall #Z-2119-2017 with the FDA Devices before acting.
The recall
Ebi Patient Care, Inc. issued this critical-severity FDA Devices recall-Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Sp….
- Critical
- severity level
- 33 units
- affected scope
- Class I
- classification
- May 31, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2119-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2119-2017) was formally reported on May 31, 2017, with the manufacturer initiating the action on April 20, 2017. It is classified under Critical severity (Class I), with a current status of Terminated. Ebi Patient Care, Inc. is listed as the recalling firm, operating out of Guaynabo, PR. Federal records list the affected scope as 33 units total.
The documented reason for this recall is: 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 mo… Distribution data in the federal record shows the product reached: Nationwide distribution only.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
33 units total
Related Recalls
6
3 from same agency
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2119-2017 |
| Date reported | May 31, 2017 |
| Date initiated | April 20, 2017 |
| Recalling firm | Ebi Patient Care, Inc. |
| Firm location | Guaynabo, PR |
| Affected scope | 33 units total |
| Distribution | Nationwide distribution only. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2119-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.. Recalled by Ebi Patient Care, Inc.. Units affected: 33 units total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2017. Severity: Critical. Recall number: Z-2119-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide distribution only..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2119-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 31, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.