ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
This recall has been terminated (originally issued April 30, 2018).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- April 16, 2018
- Posted
- April 30, 2018
- Terminated
- April 2, 2019
- Recall Number
- Z-1703-2018
- Quantity
- 2 units
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
There may be burrs on the extraction hole threads.
Distribution
The products were distributed to the following US states: FL, MO, and PA.
Lot / Code Info
Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181
Root Cause
Process control
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.