DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a load-bearing medical device (hip stem) that could lead to significant injury or device failure.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the Solution System Calcar Stems, which are used in total hip arthroplasty to replace damaged hip joints. The recall involves 1,732 total product codes 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 involving a -2mm offset articuleze head resulting in a maximum of 0.937mm radial impingement.
The FDA has classified this as a Class II recall. Consumers and healthcare providers should contact DePuy Orthopaedics for further instructions regarding the affected devices.
The recalled product
- Product
- SOL SYS 8IN CALC 1.5/18.0 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 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: 157215180 and Lot codes: 116897
- 126366
- A63GP1000
- A63GPA000
- AP2BD1000
- B19CL1000
- B19CLA000
- B19CLC000
- B3DE71000
- B3DE7A000
- B5CA41000
- C1PDC1000
- C4YBG1000
- C4YBGB
- CB1EX1000
- CC5JR1000
- CH1AC1000
- CH7EG1000
- CL5PF1000
- DD3BT1000
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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