Recall Z-0495-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer CAS
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
| Date | Dec 16, 2014 (initiated Nov 3, 2014) |
| Status | Terminated |
| Reason | Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw. |
| Root cause | Software design |
| Action | The firm, Zimmer CAS, sent an "URGENT: MEDICAL DEVICE NOTIFICATION" dated November 3, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to read this notice and be familiar with its contents; complete and return the attachment 1 CERTIFICATE OF ACKNOWLEDGEMENT form via fax to Zimmer Inc. at (574) 372-4265 or scan and email to corporatequality.postmarket@zimmer.com; and maintain a copy of the completed attachment 1 for your files. If you have questions concerning this notice, please call 514-861-4074 ext 292 or email: jean-seb |
| Quantity | 15 |
| Distribution | US Distribution in states of: AZ, CO, IL, OR, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131409 | CAS PSI KNEE SYSTEM Orthosoft, Inc., Sep 13, 2013 |