DePuy Altralinked Polyethylene Liners Recalled for Incorrect Size Labeling
DePuy Orthopaedics is recalling 20 Altralinked polyethylene liners because a size 52 liner was incorrectly labeled as size 54.
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 product (medical implant) where a sizing error could lead to improper surgical use, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 20 units of Altrx Altralinked Polyethylene liners. These medical devices are acetabular liners used during total hip arthroplasty to replace damaged hip joints and improve patient mobility. The specific units involved are identified by Catalog number 1221-36-054 and Lot Number 231859.
The recall was initiated because the products in the recalled lot were not machined according to the production router. Specifically, a size 52 cup (122136052) was machined instead of the intended size, resulting in a size 52 liner being etched and labeled as a size 54 liner. This labeling error could lead to the use of an incorrectly sized implant during surgery.
The affected products were distributed worldwide, including the United States (specifically Pennsylvania) and Canada. Healthcare providers and patients who have received or used these specific liners should contact DePuy Orthopaedics for further instructions on how to proceed.
The recalled product
- Product
- Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 20
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 (1)
- Catalog number: 1221-36-054 and Lot Number: 231859
Distribution
Distributed in 1 state:
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