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 impinge with certain heads, preventing them from locking as intended.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a load-bearing medical device (hip stem) that may fail to lock as intended, posing a significant risk of injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 1,732 units of the Solution Calcar Stem (Product Code 157215136) across various lot codes. These medical devices are used in total hip arthroplasty (THA) to replace damaged hip joints in patients with sufficient bone quality. The recall is classified as Class II by the FDA.
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 identified as 0.937mm radial impingement when paired with a -2mm offset articuleze head.
The affected products were distributed nationwide, including in all 50 states, the District of Columbia, and Guaynabo, Puerto Rico. Healthcare providers and patients who have received this specific implant should contact their surgeon or DePuy Orthopaedics for further instructions regarding the device.
The recalled product
- Product
- SOL SYS F 8 CALC 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: 157215136 and Lot codes: 169458
- AB8F51000
- AF1ED1000
- AF1EDA000
- AF1EG1000
- AF1EGA000
- AF1EGB000
- AF7KH1000
- AV7JX1000
- AW8F11000
- BR4J91000
- BT9FM1000
- BT9FMA000
- BT9FMB000
- C1PC61000
- C35D51000
- C35D5A000
- C3WCX1000
- C4YBF1000
- C5FH51000
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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