DJO Surgical Recalls Mispackaged Acetabular Liners for Hip Replacement
DJO Surgical is recalling 10 units of FMP X-alt Acetabular Liners that were mistakenly packaged and labeled as different models and sizes.
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, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a packaging and labeling error rather than a manufacturing defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
DJO Surgical is recalling 10 units of FMP X-alt Acetabular Liners. These medical devices are intended for use with DJO Surgical hip systems to replicate the kinematics of a natural hip during replacement surgery.
The recall is due to a packaging error that occurred after sterilization. Two different types and sizes of acetabular liners were mistakenly packaged into each other's outer boxes. Specifically, units labeled as Model/Catalog Number 931-28-248, Lot/Serial Number 685F1034 (an MP5 Non-Hooded, Neutral Liner) contained Model/Catalog Number 932-36-252, Lot# 728F1089 (an MP7 10-degree Hooded Liner), and vice versa.
The affected products were distributed nationwide in the USA, including Texas, Louisiana, Florida, California, and Arizona. Healthcare providers and facilities should stop using these specific lots and contact DJO Surgical for instructions on how to return the products.
The recalled product
- Product
- FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems. It is used with an acetabular shell to replicate the kinematics of a natural hip.
- Manufacturer
- Djo Surgical
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)
- Model/Catalog Number 931-28-248 Lot/Serial Number 685F1034 (an MP5 Non-Hooded
- Lot# 728F1089 (an MP7 10-degree Hooded Liner) and vice-versa
Distribution
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