CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R…
Medical device recall Z-1032-2018. Published in FDA’s Enforcement Report on Mar 21, 2018.
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 Mar 21, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 13,227 in total 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?
The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D-L CR-FLEX POR HATCP FEM D-R CR-FLEX POR HATCP FEM E-L CR-FLEX POR HATCP FEM E-R CR-FLEX POR HATCP FEM F-L CR-FLEX POR HATCP FEM F-R CR-FLEX POR HATCP FEM G-L CR-FLEX POR HATCP FEM G-R This device is indicated for patients with severe knee pain and disability
13,227 in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
65-5952-013-01 62020175 65-5952-013-02 62038825 65-5952-013-02 62110571 65-5952-014-01 61782590 65-5952-014-01 61815515 65-5952-014-01 61846120 65-5952-014-01 61855468 65-5952-014-01 61866624 65-5952-014-01 11004583 65-5952-014-01 61987911…
Every code shown here, 1,992 characters
65-5952-013-01 62020175 65-5952-013-02 62038825 65-5952-013-02 62110571 65-5952-014-01 61782590 65-5952-014-01 61815515 65-5952-014-01 61846120 65-5952-014-01 61855468 65-5952-014-01 61866624 65-5952-014-01 11004583 65-5952-014-01 61987911 65-5952-014-01 62020176 65-5952-014-01 62046099 65-5952-014-01 62068159 65-5952-014-01 62117121 65-5952-014-02 61822350 65-5952-014-02 61848475 65-5952-014-02 61899497 65-5952-014-02 61974938 65-5952-014-02 62013405 65-5952-014-02 62032575 65-5952-014-02 62068160 65-5952-014-02 62110572 65-5952-014-02 62139310 65-5952-015-01 61801431 65-5952-015-01 61822351 65-5952-015-01 61831562 65-5952-015-01 61855469 65-5952-015-01 61861694 65-5952-015-01 11004349 65-5952-015-01 11004533 65-5952-015-01 61910510 65-5952-015-01 61949553 65-5952-015-01 61936668 65-5952-015-01 61994913 65-5952-015-01 11005729 65-5952-015-01 62005727 65-5952-015-01 62025668 65-5952-015-01 62025669 65-5952-015-01 11006459 65-5952-015-01 62054539 65-5952-015-01 62074885 65-5952-015-01 11006641 65-5952-015-01 62092422 65-5952-015-01 62117122 65-5952-015-01 62139311 65-5952-015-02 61789012 65-5952-015-02 61801432 65-5952-015-02 61822358 65-5952-015-02 61831563 65-5952-015-02 61861695 65-5952-015-02 61836562 65-5952-015-02 11004148 65-5952-015-02 11004348 65-5952-015-02 11004504 65-5952-015-02 61910511 65-5952-015-02 61936669 65-5952-015-02 61949554 65-5952-015-02 61968653 65-5952-015-02 62013406 65-5952-015-02 62025670 65-5952-015-02 62025671 65-5952-015-02 62062054 65-5952-015-02 62080588 65-5952-015-02 62105374 65-5952-015-02 11007056 65-5952-015-02 62110573 65-5952-015-02 62139312 65-5952-016-01 61777546 65-5952-016-01 61795935 65-5952-016-01 61805663 65-5952-016-01 11003498 65-5952-016-01 61822352 65-5952-016-01 61824508 65-5952-016-01 61848477 65-5952-016-01 61857406 65-5952-016-01 61866625 65-5952-016-01 11004357 65-5952-016-01 11004435 65-5952-016-01 61915979 65-5952-016-01 61935649 65-5952-016-01 61949555 65-5952-016-01 61951537 65-5952-016-01 62001383…
FDA’s list runs to 11,615 characters. The first part is shown; the rest is on FDA’s record.
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.
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 29, 2017.
- FDA classified it on Mar 14, 2018.
- FDA’s Enforcement Report published it on Mar 21, 2018.
- FDA terminated it on Apr 2, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, Inc., of Warsaw, IN.
- 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.”
- FDA’s list of codes runs to 11,615 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.