DePuy Sigma HP Cemented Trochlear Implants Recalled for Elevated Revision Rates
DePuy Orthopaedics is recalling specific Sigma HP Cemented Trochlear Implants due to elevated revision rates identified during post-market surveillance.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device with elevated revision rates, which implies a risk of harm or failure, but no specific injuries or deaths are reported in the source text.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling specific lots of the SIGMA HP PFJ Cemented Trochlear Implants. These devices are standalone components of a partial knee system. The recall involves 2,110 units distributed worldwide, including the United States, Puerto Rico, and numerous international countries.
The recall was initiated based on elevated revision rates observed as part of the company's post-market surveillance process. The source text does not specify the exact nature of the mechanical failure or the specific clinical complications associated with these revisions.
Healthcare providers and patients who have received these specific implants should contact DePuy Orthopaedics or their healthcare provider for guidance on next steps. The recall covers all lots of the affected catalog numbers listed in the structured product information.
The recalled product
- Product
- (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 2,110
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 (1)
- All lots
Distribution
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