DePuy Solution Calcar Stem Recalled for Potential Impingement
DePuy Orthopaedics is recalling Solution Calcar Stems because an 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 is classified as FDA Class II, and the hazard involves a mechanical defect (impingement) in a high-risk medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the Solution System Calcar Stems (Product Code 157226225, Lot Code YG9AX1000). The recall involves 1,732 units that were distributed nationwide to various states and Puerto Rico. These medical devices are used in total hip arthroplasty to replace damaged hip joints.
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 involving a -2mm offset articuleze head resulting in a maximum of 0.937mm radial impingement.
Healthcare providers and patients who have received these implants should contact DePuy Orthopaedics for further instructions regarding the recall and potential replacement or removal of the device.
The recalled product
- Product
- SOL SYS R 9IN CALC 2.25/22.5 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 (1)
- Product Code: 157226225 and lot code: YG9AX1000
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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