DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain femoral heads.
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 high-risk medical device where a mechanical defect (impingement) could lead to harm, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution System Calcar Stems (Product Code 157215195). These medical devices are used in total hip arthroplasty to replace damaged hip joints. The recall covers specific lot codes distributed nationwide across 48 states, the District of Columbia, and Puerto Rico.
The recall was initiated after 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 impingement varies depending on the specific femoral head used, with a worst-case condition of 0.937mm radial impingement identified.
The source text does not report any specific injuries or illnesses associated with this defect. Consumers and healthcare providers should contact DePuy Orthopaedics for instructions on how to manage the recalled devices.
The recalled product
- Product
- SOL SYS 8IN CALC 1.5/19.5 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: 157215195 and Lot codes: 126367
- A34FG1000
- A63GS1000
- B19HM1000
- B3DE61000
- B46AJ1000
- BY6G81000
- C4YBH1000
- C5FH81000
- CB9L21000
- CH7EH1000
- CP8NJ1000
- D83FY1000
- DG1PB1000
- X24EW1000
- X24EX1000
- X24EY1000
- X24EYB000
- X3DC51000
- X5SB31000
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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