DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk
DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock properly with certain 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 involves a structural defect in a medical device that could lead to improper locking and potential harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution System Calcar Stem (Product Code 157226136) 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 worst-case condition involving up to 0.937mm of radial impingement.
The affected products were distributed nationwide across 49 states, the District of Columbia, and Puerto Rico. Specific lot codes are listed in the agency's recall record. The source text does not report any specific injuries, illnesses, or deaths associated with this recall.
Consumers who have purchased or received these specific hip stem components should contact DePuy Orthopaedics or their healthcare provider for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SOL SYS F 9 CALC L 13.5MM LG 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: 157226136 and Lot codes: 126676
- AB8GD1000
- AB8GDA000
- AF1EJ1000
- AF1EK1000
- AF1EKA000
- AF1EKB000
- AF7KF1000
- AT4GJ1000
- AT4GJA000
- AW8FX1000
- BR4KB1000
- C4VCSA
- C76FC1000
- C82MV1000
- D5LLL1000
- D6DE51A
- DG4FW1000
- E5RKD1
- E5RKDA
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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