DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects
DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.
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 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 recall is classified as FDA Class II and involves a structural defect in a medical device that could cause fracture, meeting the criteria for a Severe rating.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling PFC SIGMA Cruciate Retaining (CR) Cemented Femoral devices (Size 5/RT) used during primary total knee arthroplasty. The recall involves two units with Catalog Number 960015 and specific lot numbers 7810268, 7806929, and 7806934.
The devices were found to have an anomalous microstructure, specifically porosity and the presence of blocky carbides within the cobalt chrome part. These defects can decrease the overall fatigue strength of the implant, which could cause the device to fracture under loads that would normally be acceptable.
The affected devices were distributed worldwide, including in the United States (specifically Iowa, California, Kentucky, and Florida) and in Finland, Germany, Sweden, and the Czech Republic. Patients who have received these specific implants should contact their healthcare provider for evaluation.
The recalled product
- Product
- PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 2
Distribution
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