DePuy Recalls ATTUNE Revision Knee Implant Due to Burrs
DePuy Orthopaedics is recalling a specific femoral revision implant because burrs may be present on the extraction hole threads.
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 FDA Class II, which typically corresponds to a High severity score when the defect poses a risk of harm but no serious adverse consequences have been reported. The rubric assigns a score of 3 for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. has initiated a Class II recall of the ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, a femoral revision implant for the knee. The product is identified by Lot Number HD6516 and GTIN Number 10603295042280.
The recall was prompted by the potential presence of burrs on the extraction hole threads of the device. No specific illness or injury reports are mentioned in the source text, but the defect presents a risk associated with the implant's function.
The affected product was distributed to healthcare facilities in Florida, Missouri, and Pennsylvania. Consumers and medical professionals should verify if they possess this specific catalog number and lot number.
The recalled product
- Product
- ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
- Manufacturer
- DePuy Orthopaedics, Inc.
- Category
- Medical Device — Knee Implant
- 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 Number HD6516
- GTIN Number 10603295042280
Distribution
Part of a larger recall action
This product is one of 2 recalled by DePuy Orthopaedics, 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.
See all 2 products in this recall →Related recalls
Same manufacturer · DePuy Orthopaedics, Inc.
See all →- HighATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
- HighAttune Revision Tibial Insert Recalled for Excessive Gamma Radiation Exposure
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighOrthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
Same hazard · burrs
See all →- HighSize 2 Guedel airways may carry small burrs that could detach
FDA (Devices) · 2025-08-13
- HighGuedel airways may carry small burrs that could detach and be inhaled
FDA (Devices) · 2025-08-13
Similar recalls
- HighKnee Replacement Component Recalled for Adhesive Residue Risk
FDA (Devices) · 2022-02-16
- HighDepuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall
FDA (Devices) · 2026-05-06
- HighOrthopedic knee replacement component recalled for adhesive residue contamination
FDA (Devices) · 2022-02-16
- HighDepuy Synthes ATTUNE Revision Hinge Femoral implants recalled for sterility risk
FDA (Devices) · 2026-05-06
- HighDePuy Synthes ATTUNE Revision Hinge Knee Insert Components Recall
FDA (Devices) · 2026-07-08
- HighDePuy Synthes ATTUNE Revision Hinge Femoral Component Recall
FDA (Devices) · 2026-05-06