Reported Dec 10, 2014 · Terminated
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI…
Zimmer CAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer CAS · 75 Queen St #3300 · Montreal, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
16 of 16 products
Products covered by this recall # Product as published 1 BKL0398L 20-8070-002-01 2 DHA0645L 20-8070-002-01 3 DHA0646R 20-8070-002-02 4 ECO0516L 20-8070-002-01 5 GHE0651R 20-8070-002-02 6 KAD0595L 20-8070-002-01 7 KWI0523R 20-8070-002-02 8 MHA0483L 20-8070-002-01 9 MHA0484R 20-8070-002-02 10 MKE0659R 20-8070-002-02 11 MMA0728R 20-8070-002-02 12 SSC0782L 20-8070-001-01 13 TCA0582L 20-8070-002-01 14 THO0803L 20-8070-002-01 15 TMA0760L 20-8070-002-01 16 Expiration dates 5/8/14-12/31/15 - Amount recalled
- 15
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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