DePuy Solution Calcar Stems Recalled Due to 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 and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the SOLUTION System Calcar Stems (Product Code 157226165). The recall covers specific lot codes distributed nationwide across 49 states, the District of Columbia, and Puerto Rico. These medical devices are used in total hip arthroplasty to replace damaged hip joints.
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.
The source text does not specify instructions for consumers or healthcare providers regarding the recall action. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SOL SYS R 9IN CALC 2.25/16.5 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
- 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: 157226165 and Lot codes: A46AN1000
- B12LE1000
- B12LEA000
- B12LEB000
- B3XAG1000
- BP7E41000
- C76FB1000
- C82MW1000
- CK3FJ1000
- DD3BV1000
- E12BV1000
- E5WAY1000
- EF1E41000
- ER8L11000
- FG7DR1
- FJ9MB1
- X57HV1000
- X5HCC1000
- X5PGR1000
- X5PGS1000
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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