GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX…
Medical device recall Z-1060-2018. 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 GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENT NONPOROUS¿ N-K FLX GSF NP FEM SZ 0 RT N-K FLX GSF NP FEM SZ 4 LT N-K FLX GSF NP FEM SZ 4 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
00-5414-013-02 61768287 00-5414-013-02 61768287R 00-5414-013-02 77001023 00-5414-013-02 61871391 00-5414-013-02 61876203 00-5414-013-02 61889334 00-5414-013-02 61910523 00-5414-013-02 61940029 00-5414-013-02 61971424 00-5414-013-02…
Every code shown here, 1,874 characters
00-5414-013-02 61768287 00-5414-013-02 61768287R 00-5414-013-02 77001023 00-5414-013-02 61871391 00-5414-013-02 61876203 00-5414-013-02 61889334 00-5414-013-02 61910523 00-5414-013-02 61940029 00-5414-013-02 61971424 00-5414-013-02 61983528 00-5414-013-02 61994980 00-5414-013-02 62001882 00-5414-013-02 62020365 00-5414-013-02 62032695 00-5414-013-02 11006436 00-5414-013-02 62046201 00-5414-013-02 62054637 00-5414-013-02 62054637R 00-5414-013-02 62074928 00-5414-013-02 62094873 00-5414-013-02 62103499 00-5414-013-02 62117187 00-5414-013-02 62128275 00-5414-017-01 61777741 00-5414-017-01 61801560 00-5414-017-01 77001027 00-5414-017-01 61837057 00-5414-017-01 61867209 00-5414-017-01 61885276 00-5414-017-01 61889362 00-5414-017-01 61872013 00-5414-017-01 61904178 00-5414-017-01 61904178R 00-5414-017-01 61910561 00-5414-017-01 11004925 00-5414-017-01 61928674 00-5414-017-01 61952632 00-5414-017-01 61963823 00-5414-017-01 61971475 00-5414-017-01 61988083 00-5414-017-01 61994991 00-5414-017-01 62005770 00-5414-017-01 77001464 00-5414-017-01 62025843 00-5414-017-01 62041147 00-5414-017-01 62054638 00-5414-017-01 11006490 00-5414-017-01 62062144 00-5414-017-01 62074934 00-5414-017-01 62094875 00-5414-017-01 62117197 00-5414-017-02 61774297 00-5414-017-02 61824684 00-5414-017-02 61871418 00-5414-017-02 61876224 00-5414-017-02 61889363 00-5414-017-02 61899535 00-5414-017-02 61904179 00-5414-017-02 61933394 00-5414-017-02 61950165 00-5414-017-02 61928675 00-5414-017-02 61950166 00-5414-017-02 61952633 00-5414-017-02 61950164 00-5414-017-02 11005236 00-5414-017-02 11005311 00-5414-017-02 61958472 00-5414-017-02 61994989 00-5414-017-02 62001895 00-5414-017-02 62005771 00-5414-017-02 62025844 00-5414-017-02 62054634 00-5414-017-02 62046213 00-5414-017-02 62062145 00-5414-017-02 62074937 00-5414-017-02 11006896 00-5414-017-02 62104630 00-5414-017-02 62110727
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.