NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial,…
Medical device recall Z-0841-2016. Published in FDA’s Enforcement Report on Mar 2, 2016.
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 2, 2016. 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
- 115796 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?
LDPE bag containing the implant adheres to the highly polished implant surface.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes “” This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. “ CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. “ Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong¿ Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. “ Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces.”
115796, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-5960-011-51 00-5960-011-52 00-5960-012-51 00-5960-012-52 00-5960-013-51 00-5960-013-52 00-5960-014-51 00-5960-014-52 00-5960-015-51 00-5960-015-52 00-5960-016-51 00-5960-016-52 00-5960-017-51 00-5960-017-52 00-5960-018-51…
Every code shown here, 1,998 characters
Item numbers: 00-5960-011-51 00-5960-011-52 00-5960-012-51 00-5960-012-52 00-5960-013-51 00-5960-013-52 00-5960-014-51 00-5960-014-52 00-5960-015-51 00-5960-015-52 00-5960-016-51 00-5960-016-52 00-5960-017-51 00-5960-017-52 00-5960-018-51 00-5960-018-52 00-5964-011-51 00-5964-011-52 00-5964-012-51 00-5964-012-52 00-5964-013-51 00-5964-013-52 00-5964-014-51 00-5964-014-52 00-5964-015-51 00-5964-015-52 00-5964-016-51 00-5964-016-52 00-5964-017-51 00-5964-017-52 Lot numbers: 11003819 11003822 11003824 11003955 11003973 11003997 11004042 11004086 11004103 11004104 11004105 11004160 11004166 11004173 11004174 11004188 11004190 11004223 11004252 11004255 11004271 11004280 11004300 11004336 11004373 11004377 11004469 11004503 11004546 11004552 11004559 11004565 11004598 11004628 11004629 11004630 11004654 11004675 11004680 11004682 11004706 11004716 11004722 11004723 11004755 11004756 11004759 11004767 11004768 11004793 11004795 11004821 11004871 11004899 11004901 11004902 11004947 11004949 11004973 11005026 11005029 11005058 11005063 11005064 11005085 11005098 11005102 11005114 11005123 11005133 11005146 11005154 11005198 11005205 11005213 11005223 11005241 11005271 11005278 11005319 11005321 11005331 11005336 11005344 11005377 11005378 11005382 11005438 11005445 11005477 11005488 11005556 11005562 11005572 11005575 11005578 11005592 11005596 11005614 11005631 11005664 11005665 11005671 11005679 11005681 11005689 11005706 11005714 11005716 11005717 11005726 11005730 11005733 11005739 11005751 11005754 11005765 11005770 11005778 11005780 11005784 11005785 11005798 11005802 11005803 11005818 11005819 11005861 11005866 11005867 11005869 11005892 11005909 11005915 11005964 11005979 11005981 11005983 11006022 11006047 11006053 11006057 11006064 11006066 11006079 11006080 11006120 11006152 11006156 11006177 11006184 11006185 11006195 11006208 11006241 11006246 11006247 11006261 11006317 11006318 11006330 11006349 11006358 11006369 11006370 11006387 11006390 11006405 11006440…
FDA’s list runs to 49,364 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 Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
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 Jan 11, 2016.
- FDA classified it on Feb 22, 2016.
- FDA’s Enforcement Report published it on Mar 2, 2016.
- FDA terminated it on May 23, 2017.
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 49,364 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.