DePuy Recalls AltrX Hip Liners Due to Incorrect Box Labeling
DePuy Orthopaedics is voluntarily recalling 20 AltrX Polyethylene Acetabular Liners because the boxes were incorrectly labeled with the wrong product specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the box description did not match the enclosed product. This fits the rubric for moderate severity, as it is a labeling error without reported injuries or illnesses.
Plain-English summary
DePuy Orthopaedics, Inc. is issuing a voluntary recall of one lot of the AltrX Polyethylene Acetabular Liner. The recall involves 20 units of the product, specifically Reference 1221-36-452 and Lot 187460. The product was distributed worldwide, including nationwide in the United States and in Ireland.
The reason for the recall is that the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was actually a 36IDX56OD Neutral Liner. DePuy received three complaints regarding this issue in January 2012.
This product is a medical device used in combination with other implants for total hip arthroplasty. It is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation. Patients and healthcare providers should verify the specific product details against the recall information to ensure the correct implant is being used.
The recalled product
- Product
- Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 Product Usage: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- 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 (2)
- product code1221-36-452
- lot 187460.
Distribution
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