PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The…
Medical device recall Z-0495-2015. Published in FDA’s Enforcement Report on Dec 10, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 10, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 5 states named in where it went
- 15 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
15, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R…
Every code shown here, 407 characters
BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01; Expiration dates 5/8/14-12/31/15
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Distribution in states of: AZ, CO, IL, OR, and WA.
The states and territories these words name
- Arizona
- Colorado
- Illinois
- Oregon
- Washington
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 3, 2014.
- FDA classified it on Dec 2, 2014.
- FDA’s Enforcement Report published it on Dec 10, 2014.
- FDA terminated it on Feb 13, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer CAS, of Montreal, Canada.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.