LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL…
Medical device recall Z-1043-2018. 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?
LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-R LPS-FLEX OPTION FEMORAL D-L LPS-FLEX OPTION FEMORAL D-R LPS-FLEX OPTION FEMORAL E-L LPS-FLEX OPTION FEMORAL E-R LPS-FLEX OPTION FEMORAL F-L LPS-FLEX OPTION FEMORAL F-R LPS-FLEX OPTION FEMORAL G-L LPS-FLEX OPTION FEMORAL 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
00-5964-014-51 62171767 00-5964-014-52 61804723 00-5964-014-52 61804724 00-5964-014-52 61804726 00-5964-014-52 61804725 00-5964-014-52 61811767 00-5964-014-52 61811768 00-5964-014-52 61812820 00-5964-014-52 61814746 00-5964-014-52 61814749…
Every code shown here, 1,992 characters
00-5964-014-51 62171767 00-5964-014-52 61804723 00-5964-014-52 61804724 00-5964-014-52 61804726 00-5964-014-52 61804725 00-5964-014-52 61811767 00-5964-014-52 61811768 00-5964-014-52 61812820 00-5964-014-52 61814746 00-5964-014-52 61814749 00-5964-014-52 61814750 00-5964-014-52 61814747 00-5964-014-52 61814751 00-5964-014-52 61815695 00-5964-014-52 61829046 00-5964-014-52 61832272 00-5964-014-52 61832273 00-5964-014-52 61832274 00-5964-014-52 61839689 00-5964-014-52 61839691 00-5964-014-52 61847653 00-5964-014-52 61847654 00-5964-014-52 61847655 00-5964-014-52 61860204 00-5964-014-52 61860203 00-5964-014-52 61860205 00-5964-014-52 61860206 00-5964-014-52 61866693 00-5964-014-52 61869843 00-5964-014-52 61870709 00-5964-014-52 61874450 00-5964-014-52 61878263 00-5964-014-52 61878262 00-5964-014-52 61883260 00-5964-014-52 61884178 00-5964-014-52 61886312 00-5964-014-52 61890007 00-5964-014-52 61890008 00-5964-014-52 61895306 00-5964-014-52 61894531 00-5964-014-52 61895308 00-5964-014-52 61896038 00-5964-014-52 61901210 00-5964-014-52 61901211 00-5964-014-52 61902939 00-5964-014-52 61901209 00-5964-014-52 61906064 00-5964-014-52 61906381 00-5964-014-52 61915295 00-5964-014-52 61915294 00-5964-014-52 61920422 00-5964-014-52 61931652 00-5964-014-52 61931653 00-5964-014-52 61939172 00-5964-014-52 61939175 00-5964-014-52 61949694 00-5964-014-52 61936489 00-5964-014-52 61951104 00-5964-014-52 61954538 00-5964-014-52 61954539 00-5964-014-52 61954540 00-5964-014-52 61954537 00-5964-014-52 61965930 00-5964-014-52 61965929 00-5964-014-52 61973058 00-5964-014-52 61973228 00-5964-014-52 61973229 00-5964-014-52 61979767 00-5964-014-52 61979768 00-5964-014-52 61980293 00-5964-014-52 61980296 00-5964-014-52 61979766 00-5964-014-52 61988446 00-5964-014-52 61989660 00-5964-014-52 61989661 00-5964-014-52 61993903 00-5964-014-52 61993907 00-5964-014-52 61993910 00-5964-014-52 61993913 00-5964-014-52 62000966 00-5964-014-52 61989662 00-5964-014-52 62010323 00-5964-014-52 62010324…
FDA’s list runs to 38,951 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 38,951 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
-
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.