ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
FDA Recall Z-1704-2018 · Posted 2018-04-30
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Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2018-04-16
Date Terminated2019-04-02
Product Quantity1 unit
Reason for Recall
There may be burrs on the extraction hole threads.
Firm Action
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 [email protected] 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
Distribution Pattern
The products were distributed to the following US states: FL, MO, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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