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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which typically indicates a low probability of adverse health consequences, and the source text does not report any specific injuries or illnesses.
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.
- Hazard
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
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.
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