Agency classClass IOur severity:Severe FDA (Devices)·Z-0287-2019·Announced 2018-11-07

Zimmer Biomet Recalls SpF PLUS-Mini Spinal Fusion Stimulators for Cleanliness Issues

Zimmer Biomet is recalling SpF PLUS-Mini implantable spinal fusion stimulators because the company lacked adequate validation to ensure product cleanliness parameters were consistently met.

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: "Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met."

Plain-English summary

Zimmer Biomet, Inc. is recalling SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulators. The recall is due to a lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

The affected products are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels. A total of 4,879 units are involved in this recall, of which 2,982 units have been implanted and 537 have been scrapped.

The devices were distributed nationwide in the United States and in Australia. Patients who have received these implants should contact their healthcare provider for further information.

The recalled product

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
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Implantable Spinal Fusion Stimulator
Hazard: contamination

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 (20)

Item # 10-1398W - SpF Plus - Mini 60/W
Serial Numbers: 409180
409203
409209
409462
409468
409474
409687
409755
409760
409175
409181
409204
409437
409463
409469
409475
409688
409756
409754

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, 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 · Zimmer Biomet, Inc.

See all →

High
Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
Moderate
Zimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
High
Zimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
High
Zimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11

Same hazard · contamination