DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.
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 is classified as FDA Class II and involves a risk-of-harm product (mechanical failure/impingement) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution Calcar Stem (Product Code 157225210) used in total hip arthroplasty. The recall covers specific lot codes including C69C81000, X4BFN1000, X4SC81000, X57HS1000, X57HSA000, X5SB51000, YA9BP1000, YF3E91000, and YG3DF1000. These devices are intended to replace damaged hip joint articulations in patients with sufficient sound bone.
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 affected products were distributed nationwide, including in all 50 states, the District of Columbia, and Guaynabo, Puerto Rico. The source text does not report any specific illnesses or injuries associated with this recall. Healthcare providers and patients should contact DePuy Orthopaedics for further instructions regarding the replacement or removal of these devices.
The recalled product
- Product
- SOL SYS L 9IN CALC 2.25/21 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 fo
- 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 (9)
- Product Code: 157225210 and Lot codes: C69C81000
- X4BFN1000
- X4SC81000
- X57HS1000
- X57HSA000
- X5SB51000
- YA9BP1000
- YF3E91000
- and YG3DF1000.
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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