SpF PLUS-Mini — Class I medical device recall Z-0287-2019
Terminated recall by Zimmer Biomet, Inc., reported 2018-11-07, distributed nationwide. Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
| Recall number | Z-0287-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-02-19 |
| Classified | 2018-11-01 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Serial numbers | 222677, 222678, 222679, 222680, 222681, 222682, 222683, 222684, 222685, 222686, 222689, 222690, 222691, 222692, 222693, 222694, 222695, 222696, 222697, 222698, 222699, 222700, 222701, 222702, 222703 and 475 more |
| Model numbers | 10-1335M, 10-1335W, 10-1398M, 10-1398W, 2/DM, 2/DW |
Product
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
Reason for recall
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
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-0287-2019. 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.