Recall Z-0495-2015— Zimmer CAS
Class II · Terminated
Class II FDA medical device recall by Zimmer CAS, initiated 2014-11-03, terminated 2015-02-13. It names one FDA 510(k) clearance: K131409. Product: 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.. 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..
- Recalling firm
- Zimmer CAS
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-03
- Terminated
- 2015-02-13
- Firm location
- Montreal, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.