DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.
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 involves a structural defect in a high-risk medical device (hip implant) that could lead to device malfunction, fitting the criterion 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 157225150). These medical devices are used in total hip arthroplasty to replace damaged hip joints. The recall covers specific lot codes distributed nationwide across 49 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 involving a -2mm offset articuleze head resulting in a maximum of 0.937mm radial impingement.
Healthcare providers and patients who have received these implants should contact DePuy Orthopaedics for further instructions. The agency has classified this as a Class II recall, 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 2.25/15.0 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 (20)
- Product Code: 157225150 and Lot codes: 107076
- X4SE71000
- 117308
- X4SE7A000
- A38B51000
- X4SE7B000
- AV3DR1000
- YA9BN1000
- B2DB11000
- YF3E71000
- BA4GR1000
- YF3E7A000
- BA4GRA000
- YG4AF1000
- BC4HR1000
- Z47HE1000
- C49A61000
- Z4RJE1000
- C6ACN1000
- Z81H61000
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 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 · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- SevereDePuy Orthopaedics Recalls ULTIMA LX and LUSTER Hip Stems
FDA (Devices) · 2012-07-11
- HighDePuy Luster Hip Stems Recalled for Metal-on-Metal Articulation Concerns
FDA (Devices) · 2012-07-11
- HighDePuy Luster and Ultima Hip Stems Recalled for Metal-on-Metal Use
FDA (Devices) · 2012-07-11
- HighDePuy Recalls Cemented Polished Femoral Hip Stems Due to Metal-on-Metal Use
FDA (Devices) · 2012-07-11
- HighDePuy Recalls Cemented Polished Femoral Hip Stems Implanted with Metal-on-Metal Articulations
FDA (Devices) · 2012-07-11
- SevereDePuy Recalls Luster Hip Stems Implanted with Metal-on-Metal Articulations
FDA (Devices) · 2012-07-11