DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.
What this means for you
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. The hazard involves a mechanical defect (impingement) that could lead to device malfunction, but the source text does not report any specific injuries, hospitalizations, or deaths, placing it in the 'High' category for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution System Calcar Stem (Product Code 157225225, Lot codes YF3FA1000 and YG9AW1000). These medical devices are used in total hip arthroplasty to replace damaged hip joints. The recall covers products distributed nationwide across 48 states, the District of Columbia, and Puerto Rico.
An engineering analysis determined that the Solution Calcar Stem has the potential to result in impingement with a variety of femoral heads. This impingement may prevent the stem and head from locking as intended. The amount of possible impingement varies depending on the specific femoral head used, with a worst-case condition identified for a specific offset configuration.
Patients who have had this specific implant placed should contact their healthcare provider for evaluation. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 1,732
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)
- Product Code: 157225225 and Lot codes: YF3FA1000 and YG9AW1000.
Distribution
Part of a larger recall action
This product is one of 20 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 20 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 Limb Preservation System Tibial Insert Recalled for Over-Irradiation
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 · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28