Recalls / —

—#163577

Product

ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

FDA product code

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K160700

Affected lot / code info

Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181

Why it was recalled

There may be burrs on the extraction hole threads.

Root cause (FDA determination)

Process control

Action the firm took

Notification letters distributed on 4/17/18 instructed customers to perform the following: Steps to Take Please take the following actions: " Immediately return unused affected units: Note: On March 19, 2018, one unit was removed from consignment. Two units were implanted prior to the medical device recall. No additional units are in the market. " Reconciliation Form: Complete the reconciliation form and return to your sales consultant or fax to 574-371-4939 or email to klong16@its.jnj.com within five (5) days of this notice. " Records: Retain a copy of the completed reconciliation form in your files along with this notice. " Additional Notifications: o Notify surgeons at your facility by providing them with a copy of this notice. Forward this notice to others in your facility that need to be informed. Clinical Implications and Patient Impact DePuy (Ireland) is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected units.

Recalling firm

Firm

DePuy Orthopaedics, Inc.

Address

700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern

The products were distributed to the following US states: FL, MO, and PA.

Timeline

Recall initiated

2018-04-16

Posted by FDA

2018-04-30

Terminated

2019-04-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #163577. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.