DePuy Recalls Two Knee Implants Due to Thread Burrs
DePuy Orthopaedics is recalling two ATTUNE Revision CRS Femoral LT knee implants because burrs may be present on the extraction hole threads.
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 is FDA Class II, which typically corresponds to a High severity score when the defect poses a risk of harm but no serious injury has been reported. The potential for device failure due to burrs on extraction threads warrants this classification.
Plain-English summary
DePuy Orthopaedics, Inc. has initiated a Class II recall of specific ATTUNE Revision CRS Femoral LT SZ 5 Cemented femoral revision knee implants. The affected products are identified by Catalog No. 150440105 and include Lot Numbers HC1179 and HC1183, both associated with GTIN Number 10603295042181. A total of two units are subject to this recall.
The reason for the recall is that burrs may be present on the extraction hole threads of these implants. The presence of such burrs could potentially compromise the device's performance or safety during use.
These products were distributed to patients in Florida, Missouri, and Pennsylvania. Healthcare providers and patients should contact DePuy Orthopaedics for further information regarding this recall.
The recalled product
- Product
- ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
- Manufacturer
- DePuy Orthopaedics, Inc.
- Category
- Medical Device — Knee Implant
- Hazard
- Affected units
- 2
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 (3)
- Lot Number HC1179
- GTIN Number 10603295042181
- Lot Number HC1183
Distribution
Part of a larger recall action
This product is one of 2 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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