CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE…
Medical device recall Z-1042-2018. 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 OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP SIZE D/L CR OPTION FEM COMP SIZE D/R CR OPTION FEM COMP SIZE E/L CR OPTION FEM COMP SIZE E/R CR OPTION FEM COMP SIZE F/L CR OPTION FEM COMP SIZE F/R CR OPTION FEM COMP SIZE G/L CR OPTION FEM COMP SIZE 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
00-5966-013-01 61893236 00-5966-013-01 61939720 00-5966-013-01 61976414 00-5966-013-01 61997338 00-5966-013-01 61997339 00-5966-013-01 62164866 00-5966-013-01 62173181 00-5966-013-02 61893622 00-5966-013-02 61939721 00-5966-013-02 61976415…
Every code shown here, 1,992 characters
00-5966-013-01 61893236 00-5966-013-01 61939720 00-5966-013-01 61976414 00-5966-013-01 61997338 00-5966-013-01 61997339 00-5966-013-01 62164866 00-5966-013-01 62173181 00-5966-013-02 61893622 00-5966-013-02 61939721 00-5966-013-02 61976415 00-5966-013-02 61997340 00-5966-013-02 61998618 00-5966-013-02 62142586 00-5966-013-02 62172419 00-5966-014-01 61782655 00-5966-014-01 61850922 00-5966-014-01 61855960 00-5966-014-01 61873439 00-5966-014-01 61883263 00-5966-014-01 61883264 00-5966-014-01 61886303 00-5966-014-01 61890020 00-5966-014-01 61890021 00-5966-014-01 61890694 00-5966-014-01 61896063 00-5966-014-01 61916149 00-5966-014-01 61918723 00-5966-014-01 61918967 00-5966-014-01 61924446 00-5966-014-01 61933809 00-5966-014-01 61943608 00-5966-014-01 61946984 00-5966-014-01 11400307 00-5966-014-01 61971724 00-5966-014-01 61971725 00-5966-014-01 61974122 00-5966-014-01 61974123 00-5966-014-01 61978521 00-5966-014-01 61978522 00-5966-014-01 61989037 00-5966-014-01 61996346 00-5966-014-01 61996347 00-5966-014-01 62002067 00-5966-014-01 62002068 00-5966-014-01 61988452 00-5966-014-01 62022322 00-5966-014-01 62033088 00-5966-014-01 62038014 00-5966-014-01 62047986 00-5966-014-01 62047985 00-5966-014-01 62067952 00-5966-014-01 62073104 00-5966-014-01 62080815 00-5966-014-01 62085948 00-5966-014-01 62092287 00-5966-014-01 62110232 00-5966-014-01 62110233 00-5966-014-01 62119544 00-5966-014-01 62123030 00-5966-014-01 62133158 00-5966-014-01 62139972 00-5966-014-01 62139995 00-5966-014-01 62142356 00-5966-014-01 62152617 00-5966-014-01 62152618 00-5966-014-01 62164318 00-5966-014-01 62173182 00-5966-014-02 61851720 00-5966-014-02 61874459 00-5966-014-02 61879226 00-5966-014-02 61883265 00-5966-014-02 61883266 00-5966-014-02 61893232 00-5966-014-02 61890696 00-5966-014-02 61893234 00-5966-014-02 61902949 00-5966-014-02 61916150 00-5966-014-02 61918968 00-5966-014-02 61918969 00-5966-014-02 61924447 00-5966-014-02 61933810 00-5966-014-02 61937797 00-5966-014-02 61947190…
FDA’s list runs to 13,679 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 13,679 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.