Biomet PerFuse Decompression Instrument Recall Due to Missing Parts
Biomet, Inc. is recalling 22 PerFuse Decompression Instruments because missing Trocar and Plunger Assemblies could delay surgery by more than 30 minutes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 II. The hazard involves a procedural delay rather than direct physical injury or death, fitting the criteria for moderate severity involving operational risks without reported harm.
Plain-English summary
Biomet, Inc. is recalling 22 units of the PerFuse Decompression Instrument (PN: 800-0541, Lot: 100650). The instrument is designed to access the femoral head for decompression.
The recall is being conducted because the Trocar and Plunger Assemblies are missing from the instrument. This defect could result in a delay in surgery greater than 30 minutes.
The affected units were distributed in the US states of California, Georgia, Minnesota, and Ohio, as well as in the Netherlands. Healthcare facilities should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- PerFuse Decompression Instrument PN: 800-0541, Lot:100650. Designed to access the femoral head for decompression.
- Manufacturer
- Biomet, Inc.
- Affected units
- 22
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 (2)
- PerFuse Decompression Instrument PN: 800-0541
- Lot:100650
Distribution
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