DePuy LPS Lower Extremity Dovetail Intercalary Component Recall for Fracture Risk
DePuy Orthopaedics is recalling LPS Lower Extremity Dovetail Intercalary components due to a potential for fracture under certain physiological loads.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is 'Class I'. According to the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical) regardless of other factors.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the LPS Lower Extremity Dovetail Intercalary component. This medical device is intended for use in the replacement of the mid-shaft portion of the femur.
The recall is being issued because the component has the potential for fracture of the female component when exposed to certain physiological loads. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
A total of 58 units were distributed in the United States and 39 units were distributed outside the U.S. The affected units were distributed worldwide, including in the United States (specifically in FL, GA, ID, KS, KY, MI, MO, NC, NV, NY, OH, OK, PA, TN, TX, VA, and WA) and in Australia, Canada, England, Germany, India, County Cork, Ireland, and Turkey. Patients who have had this component implanted should contact their healthcare provider for further evaluation and instructions.
The recalled product
- Product
- LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
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)
- CATALOG NO. : Part Number: 1987-19-055 and lot numbers:130896
- 132131
- 132133
- 209461
- 209466
- 219843
- 232972
- 295965
- 310189
- 336843
- 349283
- 352878
- 374125
- 379089
- A1TAR1
- A2AGN1
- A2AGS1
- A2AGT1
- A2AGV1
- B2VAL1
Distribution
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