Recall Z-1123-2019 · KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Encore Medical, Lp
Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085
| Date | Sep 21, 2018 |
| Status | Terminated |
| Reason | Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery |
| Root cause | Other |
| Action | On 09/21/18, Urgent Field Safety Notices, updated surgical techniques, and Acknowledgement and Receipt Forms were emailed to Surgical Sales Agents. The Surgical Technique provides instructions on use of the manual T-handle as the primary tightening method. It also provides instructions for use of the torque wrench to ensure that the readout for the torque wrench is at "0" before torque is applied. Sales agents were asked to affirm that they have read and understood the updated Surgical Technique information provided in the Field Safety Notice Bulletin. They were also asked to affirm that they |
| Quantity | 22 |
| Distribution | US: TN, MN, TX, CO, IL, IN, OH, SC, MS, MI, RI, PA, ME, NY, WA, MO, AR, OK, LA, AL, FL, GA, UT, AZ, CA, NV,. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163497 | EXPRT Revision Hip System - EXPRT Hip Distal Stem, EXPRT Hip Standard Offset Proximal Body Implant, EXPRT Hip Latera Encore Medical L.P., Mar 2, 2017 |