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.
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution System Calcar Stem. This medical device is used in total hip arthroplasty to replace damaged hip joints. The recall is based on an engineering analysis that determined 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 worst-case condition involving up to 0.937mm of radial impingement.
The affected products were distributed nationwide across 48 states, the District of Columbia, and Guaynabo, Puerto Rico. The specific product code is 157226180, and the recall includes 24 specific lot codes. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare providers and patients should contact DePuy Orthopaedics or their medical provider for instructions on how to proceed with the recall. The source text does not specify a particular action for consumers beyond the standard recall notification process.
The recalled product
- Product
- SOL SYS R 9IN CALC 2.25/18 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: 157226180 and Lot codes: 118843
- A31E61000
- B12LF1000
- B2PAW1000
- BC4HS1000
- C5FH91000
- C76FD1000
- CK3FM1000
- DG4FX1000
- E6BKV1
- ER8L21000
- X34C41000
- X49FG1000
- X4SE81000
- X4SE91000
- X53B21000
- YF4A61000
- YF4A71000
- YF4A7A000
- YG4AH1000
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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