LPS OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION…
Medical device recall Z-1035-2018. 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 OPTION FEMORAL C-L LPS OPTION FEMORAL C-R LPS OPTION FEMORAL D-L LPS OPTION FEMORAL D-R LPS OPTION FEMORAL E-L LPS OPTION FEMORAL E-R LPS OPTION FEMORAL F-L LPS OPTION FEMORAL F-R LPS OPTION FEMORAL G-L LPS OPTION FEMORAL G-R LPS OPTION FEMORAL H-L 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
00-5996-013-01 61782577 00-5996-013-01 61863954 00-5996-013-01 61924457 00-5996-013-01 61977562 00-5996-013-01 61977561 00-5996-013-01 62003777 00-5996-013-01 62003778 00-5996-013-01 62008974 00-5996-013-01 62008972 00-5996-013-01 62051204…
Every code shown here, 1,992 characters
00-5996-013-01 61782577 00-5996-013-01 61863954 00-5996-013-01 61924457 00-5996-013-01 61977562 00-5996-013-01 61977561 00-5996-013-01 62003777 00-5996-013-01 62003778 00-5996-013-01 62008974 00-5996-013-01 62008972 00-5996-013-01 62051204 00-5996-013-01 62091551 00-5996-013-01 62100471 00-5996-013-01 62107986 00-5996-013-01 62107987 00-5996-013-01 62118558 00-5996-013-01 62124601 00-5996-013-01 62134289 00-5996-013-01 62151257 00-5996-013-01 62161217 00-5996-013-01 62170068 00-5996-013-01 62172687 00-5996-013-02 61782578 00-5996-013-02 61850932 00-5996-013-02 61864885 00-5996-013-02 11400172 00-5996-013-02 61922268 00-5996-013-02 61924458 00-5996-013-02 61974046 00-5996-013-02 61974131 00-5996-013-02 61974132 00-5996-013-02 61974133 00-5996-013-02 61977563 00-5996-013-02 61978530 00-5996-013-02 61989687 00-5996-013-02 61990926 00-5996-013-02 62003779 00-5996-013-02 62004852 00-5996-013-02 62009310 00-5996-013-02 62009311 00-5996-013-02 62080341 00-5996-013-02 62091041 00-5996-013-02 62100473 00-5996-013-02 62109165 00-5996-013-02 62112981 00-5996-013-02 62124859 00-5996-013-02 62134305 00-5996-013-02 62152623 00-5996-013-02 62161218 00-5996-013-02 62170070 00-5996-014-01 61782547 00-5996-014-01 61782562 00-5996-014-01 61804267 00-5996-014-01 61804268 00-5996-014-01 61808651 00-5996-014-01 61808647 00-5996-014-01 61809730 00-5996-014-01 61809731 00-5996-014-01 61820657 00-5996-014-01 61820730 00-5996-014-01 61820668 00-5996-014-01 61829136 00-5996-014-01 61835341 00-5996-014-01 61835342 00-5996-014-01 61835835 00-5996-014-01 61835836 00-5996-014-01 61843606 00-5996-014-01 61844576 00-5996-014-01 61844577 00-5996-014-01 61844578 00-5996-014-01 61844906 00-5996-014-01 61844907 00-5996-014-01 61848266 00-5996-014-01 61848267 00-5996-014-01 61848268 00-5996-014-01 61848269 00-5996-014-01 61848270 00-5996-014-01 61853388 00-5996-014-01 61853389 00-5996-014-01 61853390 00-5996-014-01 61855970 00-5996-014-01 61855971 00-5996-014-01 61868871 00-5996-014-01 61868872…
FDA’s list runs to 38,879 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 38,879 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.