CR-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP…
Medical device recall Z-1031-2018. 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-FLX POR HATCP FEM C-L MINUS CR-FLX POR HATCP FEM C-R MINUS CR-FLX POR HATCP FEM D-L MINUS CR-FLX POR HATCP FEM D-R MINUS CR-FLX POR HATCP FEM E-L MINUS CR-FLX POR HATCP FEM E-R MINUS CR-FLX POR HATCP FEM F-L MINUS CR-FLX POR HATCP FEM F-R MINUS CR-FLX POR HATCP FEM G-L MINUS CR-FLX POR HATCP FEM G-R MINUS 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
65-5952-013-05 61819644 65-5952-013-05 61855471 65-5952-013-05 11004433 65-5952-013-06 62056868 65-5952-014-05 61782591 65-5952-014-05 11003623 65-5952-014-05 61987912 65-5952-014-05 62104150 65-5952-014-06 61835232 65-5952-014-06 62038826…
Every code shown here, 1,655 characters
65-5952-013-05 61819644 65-5952-013-05 61855471 65-5952-013-05 11004433 65-5952-013-06 62056868 65-5952-014-05 61782591 65-5952-014-05 11003623 65-5952-014-05 61987912 65-5952-014-05 62104150 65-5952-014-06 61835232 65-5952-014-06 62038826 65-5952-014-06 62132128 65-5952-015-05 61782592 65-5952-015-05 61822359 65-5952-015-05 61857405 65-5952-015-05 11004436 65-5952-015-05 61939607 65-5952-015-05 62020177 65-5952-015-05 62046101 65-5952-015-05 62122758 65-5952-015-06 61805662 65-5952-015-06 11003505 65-5952-015-06 61848476 65-5952-015-06 11004261 65-5952-015-06 61921288 65-5952-015-06 61968654 65-5952-015-06 62001382 65-5952-015-06 62025672 65-5952-015-06 62074886 65-5952-015-06 62128161 65-5952-016-05 61801433 65-5952-016-05 61836563 65-5952-016-05 61857407 65-5952-016-05 11004258 65-5952-016-05 11004438 65-5952-016-05 61928636 65-5952-016-05 61951539 65-5952-016-05 62020178 65-5952-016-05 62056869 65-5952-016-05 62092424 65-5952-016-05 62139313 65-5952-016-06 61777547 65-5952-016-06 61822354 65-5952-016-06 61857408 65-5952-016-06 11004434 65-5952-016-06 61904112 65-5952-016-06 61939609 65-5952-016-06 62002454 65-5952-016-06 62020219 65-5952-016-06 62062056 65-5952-016-06 62104151 65-5952-017-05 61824510 65-5952-017-05 61893908 65-5952-017-05 61939612 65-5952-017-05 62005729 65-5952-017-05 62025675 65-5952-017-05 62086012 65-5952-017-05 62132131 65-5952-017-06 11003018 65-5952-017-06 61795937 65-5952-017-06 61822355 65-5952-017-06 11003671 65-5952-017-06 61861698 65-5952-017-06 61846121 65-5952-017-06 11004260 65-5952-017-06 61915980 65-5952-017-06 61987914 65-5952-017-06 62020182 65-5952-017-06 62038827 65-5952-017-06 62105368
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.”
- 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.