DePuy Solution Calcar Stems Recalled Due to Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock as intended with certain femoral heads.
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 is classified as FDA Class II, and the source describes a mechanical defect (impingement) that may prevent the device from locking as intended, representing a risk of harm where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution System Calcar Stem, a medical device used in total hip arthroplasty. The recall was initiated after 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 affected product is distributed nationwide across 48 states, the District of Columbia, and Guaynabo, Puerto Rico. The recall includes specific product code 157225180 and a list of 25 specific lot codes. The device is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients with sufficient sound bone.
Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the recall and potential replacement or repair of the affected devices.
The recalled product
- Product
- SOL SYS L 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: 157225180 and Lot codes: B19HN1000
- B19HNA000
- B3FAF1000
- BF6A21000
- C32GEA
- C5PRY1000
- C61CD1000
- CD1EW1000
- EE5K61000
- X33GC1000
- X49FV1000
- X4KF91000
- X4KGA1000
- X4KGB1000
- X5SB41000
- X5SB4A000
- X5SB4B000
- X5SB4C000
- Y14GJ1000
- Y14GJA000
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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