FDA Device recall Z-2118-2017
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator
- FDA Device
- Class I
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class I recall of 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator by Ebi Patient Care, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2118-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-04-20 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ebi Patient Care |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626…Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and 224667. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2118-2017%22
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