The Recall Desk
HighFDA (Devices)·Z-0590-2013·Announced 2012-12-26

DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

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 involves a risk-of-harm medical device where the stem may not lock as intended, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution System Calcar Stem (Product Code 157226195). The recall covers specific lot codes including B2LAC1000, BN1K6A000, CE3FH1000, CL5PJ1000, X5GB61000, X5GB6A000, X5HCV1000, X5PGT1000, X5PGV1000, X5PGW1000, YF4A81000, YF5DP1000, YG7D61000, and Z41AV1000. 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 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 48 states, the District of Columbia, and Guaynabo, Puerto Rico. The source text does not report any specific illnesses, injuries, or deaths 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 R 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.
Category
Medical Device — Orthopedic Implant
Hazard
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 (14)

  • Product Code: 157226195 and Lot codes: B2LAC1000
  • BN1K6A000
  • CE3FH1000
  • CL5PJ1000
  • X5GB61000
  • X5GB6A000
  • X5HCV1000
  • X5PGT1000
  • X5PGV1000
  • X5PGW1000
  • YF4A81000
  • YF5DP1000
  • YG7D61000
  • and Z41AV1000.

Distribution

Distributed nationwide across the United States.

The notice also names 47 states specifically:

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.

See all 20 products in this recall →

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