LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT…
Medical device recall Z-1044-2018. 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 PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX PRECOAT FEMORAL G-L LPS-FLEX PRECOAT FEMORAL G-R LPS-FLEX PRECOAT FEMORAL H-L LPS-FLEX PRECOAT FEMORAL H-R¿ LPS-FLEX POROUS FEMORAL E-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
00-5960-012-51 62163094 00-5960-012-52 114687 00-5960-012-52 62162221 00-5960-013-51 61418001 00-5960-013-51 11006251 00-5960-013-51 62119540 00-5960-013-51 62130947 00-5960-013-51 62174403 00-5960-013-52 62120588 00-5960-013-52 62130963…
Every code shown here, 1,988 characters
00-5960-012-51 62163094 00-5960-012-52 114687 00-5960-012-52 62162221 00-5960-013-51 61418001 00-5960-013-51 11006251 00-5960-013-51 62119540 00-5960-013-51 62130947 00-5960-013-51 62174403 00-5960-013-52 62120588 00-5960-013-52 62130963 00-5960-014-51 11400330 00-5960-014-51 11006176 00-5960-014-51 11006333 00-5960-014-51 62120591 00-5960-014-51 62131197 00-5960-014-51 62134257 00-5960-014-51 62170032 00-5960-014-52 62012423 00-5960-014-52 11006544 00-5960-014-52 62061891 00-5960-014-52 62121191 00-5960-014-52 62131248 00-5960-014-52 62134703 00-5960-014-52 62171835 00-5960-014-52 62174384 00-5960-015-51 62121224 00-5960-015-51 62131267 00-5960-015-51 62134706 00-5960-015-51 62168365 00-5960-015-52 61641772 00-5960-015-52 62121768 00-5960-015-52 62121770 00-5960-015-52 62131277 00-5960-015-52 62135957 00-5960-016-51 61793525 00-5960-016-51 61784879 00-5960-016-51 62121790 00-5960-016-51 62121792 00-5960-016-51 62131249 00-5960-016-51 62131284 00-5960-016-51 11400431 00-5960-016-51 62171784 00-5960-016-52 61794705 00-5960-016-52 11005960 00-5960-016-52 62122521 00-5960-016-52 62133156 00-5960-016-52 62137533 00-5960-017-51 114691 00-5960-017-51 62122653 00-5960-017-51 62131221 00-5960-017-51 62137511 00-5960-017-51 62168367 00-5960-017-52 62122857 00-5960-017-52 62128361 00-5960-017-52 62132861 00-5960-018-51 11004155 00-5960-018-51 11005166 00-5960-018-51 11005910 00-5960-018-52 11004157 00-5960-018-52 11005164 00-5960-018-52 11005165 00-5950-015-05 61823885 00-5950-015-05 61858477 00-5950-015-05 61876281 00-5950-015-05 61953097 00-5950-015-05 61999987 00-5950-015-05 62030633 00-5950-015-05 62054070 00-5950-015-05 62091541 00-5950-015-05 62138242 00-5950-015-05 62172417 00-5950-012-02 61777545 00-5950-013-01 61854815 00-5950-013-01 62092032 00-5950-013-01 62171087 00-5950-013-02 62005882 00-5950-013-02 62030313 00-5950-013-06 11003339 00-5950-013-06 62171088 00-5950-014-01 61817750 00-5950-014-01 61827935 00-5950-014-01 61832285 00-5950-014-01 61835326…
FDA’s list runs to 17,011 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 17,011 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.