Agency classClass IOur severity:Severe FDA (Devices)·Z-2118-2017·Announced 2017-05-31

EBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity

EBI Patient Care is recalling 33 SpF-XL IIB implantable stimulators because routine monitoring found higher than allowed cytotoxicity levels.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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…"

Plain-English summary

EBI Patient Care, Inc. is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products. The recall involves 33 units of the 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator, which is indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

The action was taken due to higher than allowed cytotoxicity levels found during routine process monitoring with the product. The affected units were distributed nationwide.

Patients who have received these devices should contact their healthcare provider for further instructions. The specific serial numbers for the affected units are listed in the official recall documentation.

The recalled product

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.
Manufacturer: EBI Patient Care, Inc.
Category: Medical Device — Implantable Stimulator
Hazard: cytotoxicity
Affected units: 33

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

and 224667.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by EBI Patient Care, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · EBI Patient Care, Inc.

See all →

Severe
EBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity
FDA (Devices) · 2017-05-31

Same hazard · cytotoxicity