Recall Z-1703-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
| Date | Apr 30, 2018 (initiated Apr 16, 2018) |
| Status | Terminated |
| Reason | There may be burrs on the extraction hole threads. |
| Root cause | Process control |
| 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 klong16@its.jnj.com within five (5) days of this notice. " Records: Retain a copy of the completed reconciliation form in yo |
| Quantity | 2 units |
| Distribution | The products were distributed to the following US states: FL, MO, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160700 | ATTUNE Revision Knee System Depuy(Ireland), Jun 10, 2016 |