ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

FDA device recall Z-1704-2018 · posted 2018-04-30 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

There may be burrs on the extraction hole threads.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

JWH

Quantity affected

1 unit

Distribution

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

Date initiated

2018-04-16

Date posted

2018-04-30

Date terminated

2019-04-02

Location

Warsaw, IN

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