DePuy P.F.C. SIGMA Revision Knee Distal Augment Recall
DePuy Orthopaedics is recalling one P.F.C. SIGMA Revision Knee System Distal Augment because it may be missing the screw/collet assembly. The device was not distributed in the United States.
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, and the defect involves a missing component in a medical device. No injuries or illnesses are reported in the source text, and the distribution was limited to one unit in a foreign country, fitting the criteria for a moderate severity recall.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling one unit of the P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830. The recall is being conducted because the unit may be missing the screw/collet assembly.
The affected device is identified by Lot C2KJ24 and GTIN 10603295234135. According to the source text, the devices were not distributed in the United States. The devices were distributed to Great Britain.
The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled unit, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 1
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)
- Lot: C2KJ24
- GTIN: 10603295234135
Distribution
Distribution scope not specified by the agency.
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