GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM…
Medical device recall Z-1061-2018. 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?
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM FEMORAL COMPONENT¿ N-K FLX GSM POR FEM SZ 2 RT N-K FLX GSM POR FEM SZ 3 LT N-K FLX GSM POR FEM SZ 4 LT N-K FLX GSM POR FEM SZ 4 RT N-K FLX GSM POR FEM SZ 5 LT N-K FLX GSM POR FEM SZ 5 RT Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
13,227 in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00-5412-015-02 61777756 00-5412-015-02 11003149 00-5412-015-02 61782977 00-5412-015-02 61796047 00-5412-015-02 61806563 00-5412-015-02 61806562 00-5412-015-02 61867212 00-5412-015-02 61867213 00-5412-015-02 61872035 00-5412-015-02 61871424…
Every code shown here, 1,992 characters
00-5412-015-02 61777756 00-5412-015-02 11003149 00-5412-015-02 61782977 00-5412-015-02 61796047 00-5412-015-02 61806563 00-5412-015-02 61806562 00-5412-015-02 61867212 00-5412-015-02 61867213 00-5412-015-02 61872035 00-5412-015-02 61871424 00-5412-015-02 11004422 00-5412-015-02 11004477 00-5412-015-02 61876226 00-5412-015-02 61885240 00-5412-015-02 61889370 00-5412-015-02 61894436 00-5412-015-02 61899511 00-5412-015-02 11001440 00-5412-015-02 61904154 00-5412-015-02 61916029 00-5412-015-02 61921361 00-5412-015-02 61928677 00-5412-015-02 61940207 00-5412-015-02 61952635 00-5412-015-02 61963807 00-5412-015-02 61968948 00-5412-015-02 61988106 00-5412-015-02 11005840 00-5412-015-02 61983536 00-5412-015-02 61975655 00-5412-015-02 61995014 00-5412-015-02 61988107 00-5412-015-02 62001897 00-5412-015-02 62013575 00-5412-015-02 62005775 00-5412-015-02 62013586 00-5412-015-02 62013587 00-5412-015-02 11006300 00-5412-015-02 62020383 00-5412-015-02 62025800 00-5412-015-02 62025801 00-5412-015-02 62041160 00-5412-015-02 62032711 00-5412-015-02 62054603 00-5412-015-02 62056958 00-5412-015-02 62062122 00-5412-015-02 62068182 00-5412-015-02 62080694 00-5412-015-02 62074905 00-5412-015-02 62086883 00-5412-015-02 62104646 00-5412-015-02 62104205 00-5412-015-02 62110690 00-5412-015-02 62117168 00-5412-015-02 62122805 00-5412-015-02 62128264 00-5412-016-01 61777757 00-5412-016-01 61777758 00-5412-016-01 61777751 00-5412-016-01 61789818 00-5412-016-01 61782969 00-5412-016-01 61782978 00-5412-016-01 61789819 00-5412-016-01 61789821 00-5412-016-01 61789820 00-5412-016-01 11003194 00-5412-016-01 61796051 00-5412-016-01 61796048 00-5412-016-01 61796049 00-5412-016-01 61796050 00-5412-016-01 11003207 00-5412-016-01 61806564 00-5412-016-01 61806565 00-5412-016-01 61810244 00-5412-016-01 61810277 00-5412-016-01 61810278 00-5412-016-01 61822640 00-5412-016-01 61824650 00-5412-016-01 61831766 00-5412-016-01 61831767 00-5412-016-01 61831768 00-5412-016-01 61831769 00-5412-016-01 61837030…
FDA’s list runs to 13,280 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 13,280 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.