DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling 1,732 Solution Calcar Stems because engineering analysis found they may not lock properly with certain femoral heads, posing a risk of impingement.
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 medical device where the stem may fail to lock as intended, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution System Calcar Stem (Product Code 157225195). The recall covers specific lot codes including B2WBP1000, B34H81000, and others, 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 possible impingement varies depending on the specific femoral head used, with a worst-case condition identified as 0.937mm radial impingement when paired with a -2mm offset articuleze head.
These devices are used in total hip arthroplasty to replace damaged hip joints. Patients who have had this specific stem implanted should contact their healthcare provider to discuss the findings and determine if any action is necessary.
The recalled product
- Product
- SOL SYS L 9IN CALC 2.25/19.5 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…
- 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: 157225195 and Lot codes: B2WBP1000
- B34H81000
- B34H8A000
- BB1AJ1000
- CD1EX1000
- D5NEH1000
- X4SF21000
- X5FBT1000
- X5FBTA000
- X5FBV1000
- X5FBVA000
- X5PGM1000
- X5PGN1000
- X5PGNA000
- X83KD1000
- YF3E81000
- YF6AF1000
- YG4AG1000
- ZA7JB1000
- and ZA7JBA000.
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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