DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain femoral heads, preventing the stem and head from locking as intended.
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 involves a medical device with a mechanical defect that could prevent proper locking, posing a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the Solution System Calcar Stems (Product Code 157215165) due to a potential design issue. An engineering analysis determined that the 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, with the amount of impingement varying depending on the specific femoral head used.
The recall covers 1,732 total units across various lot codes. The products were distributed nationwide to 49 states, the District of Columbia, and Guaynabo, Puerto Rico. The Solution System Calcar Stems are used in total hip arthroplasty to replace damaged hip joint articulations in patients with sufficient sound bone.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SOL SYS 8IN CALC 1.5/16.5 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 for
- 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: 157215165 and Lot codes: 111621
- FG9KT1
- 126365
- X3VB41000
- A19GL1000
- X4SC51000
- A3XF31000
- X4SC5A000
- A3XF3A000
- X4SC61000
- A63GR1000
- X53B11000
- A6AE81000
- X5REA1000
- A6AE8A000
- YF4AX1000
- AY7KN1000
- YF4AXA000
- AY7KNA000
- YG2CY1000
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.
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