EBI Patient Care, Inc.
Guaynabo, PR, US
EBI PATIENT CARE, INC. appears in FDA device records in Guaynabo, PR. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003435252 | 3003435252 | EBI PATIENT CARE, INC. | 484 Calle E, GUAYNABO, PR 00969 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2119-2017 | 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 cytotoxicity levels found during routine process monitoring with the product. | Class I | Terminated | |
| Z-2118-2017 | 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. | 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. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain