The Recall Desk
HighFDA (Devices)·Z-1704-2018·Announced 2018-05-16

DePuy Recalls ATTUNE Revision Knee Implant Due to Burrs

DePuy Orthopaedics is recalling a specific femoral revision implant 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 adverse consequences have been reported. The rubric assigns a score of 3 for risk-of-harm products where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. has initiated a Class II recall of the ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, a femoral revision implant for the knee. The product is identified by Lot Number HD6516 and GTIN Number 10603295042280.

The recall was prompted by the potential presence of burrs on the extraction hole threads of the device. No specific illness or injury reports are mentioned in the source text, but the defect presents a risk associated with the implant's function.

The affected product was distributed to healthcare facilities in Florida, Missouri, and Pennsylvania. Consumers and medical professionals should verify if they possess this specific catalog number and lot number.

The recalled product

Product
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Knee Implant
Hazard
Affected units
1

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)

  • Lot Number HD6516
  • GTIN Number 10603295042280

Distribution

Distributed in 3 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · DePuy Orthopaedics, Inc.

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Same hazard · burrs

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