10-1335M — Class I medical device recall Z-2118-2017
Terminated recall by EBI Patient Care, Inc., reported 2017-05-31, distributed nationwide. Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spi
| Recall number | Z-2118-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | EBI Patient Care, Inc., Guaynabo, PR, United States |
| Recall initiated | 2017-04-20 |
| Classified | 2017-05-25 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2018-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 33 units |
| Serial numbers | 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2118-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.