NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee,…
Medical device recall Z-0834-2016. 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
- 88389 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 Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage “” 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 and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only.”
88389, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-5992-017-91 00-5992-017-92 00-5994-013-01 00-5994-013-02 00-5994-013-91 00-5994-013-92 00-5994-014-01 00-5994-014-02 00-5994-014-91 00-5994-014-92 00-5994-015-01 00-5994-015-02 00-5994-015-91 00-5994-015-92 00-5994-016-01…
Every code shown here, 1,995 characters
Item numbers: 00-5992-017-91 00-5992-017-92 00-5994-013-01 00-5994-013-02 00-5994-013-91 00-5994-013-92 00-5994-014-01 00-5994-014-02 00-5994-014-91 00-5994-014-92 00-5994-015-01 00-5994-015-02 00-5994-015-91 00-5994-015-92 00-5994-016-01 00-5994-016-02 00-5994-016-91 00-5994-016-92 00-5994-017-01 00-5994-017-02 00-5994-017-91 00-5994-017-92 00-5996-011-01 00-5996-011-02 00-5996-011-51 00-5996-011-52 00-5996-012-01 00-5996-012-02 00-5996-012-51 00-5996-012-52 00-5996-013-01 00-5996-013-02 00-5996-013-51 00-5996-013-52 00-5996-014-01 00-5996-014-02 00-5996-014-51 00-5996-014-52 00-5996-015-01 00-5996-015-02 00-5996-015-51 00-5996-015-52 00-5996-016-01 00-5996-016-02 00-5996-016-51 00-5996-016-52 00-5996-017-01 00-5996-017-02 00-5996-017-51 00-5996-017-52 00-5996-017-91 00-5996-017-92 00-5996-018-01 00-5996-018-02 00-5996-018-51 00-5996-018-52 00-5996-018-91 00-5996-018-92 Lot numbers: 11002128 11002763 11003329 11003332 11003363 11003364 11003379 11003386 11003422 11003470 11003480 11003481 11003483 11003484 11003485 11003486 11003527 11003529 11003530 11003531 11003572 11003573 11003582 11003604 11003614 11003616 11003632 11003648 11003656 11003657 11003662 11003676 11003677 11003678 11003679 11003681 11003682 11003683 11003684 11003693 11003694 11003808 11003809 11003811 11003831 11003839 11003845 11003846 11003920 11003936 11003946 11003948 11003983 11004007 11004008 11004038 11004044 11004057 11004062 11004088 11004142 11004185 11004214 11004250 11004253 11004268 11004270 11004297 11004301 11004307 11004356 11004358 11004458 11004529 11004633 11004634 11004650 11004674 11004703 11004771 11004794 11004822 11004824 11004831 11004832 11004854 11004857 11004859 11004867 11004884 11004893 11004900 11004903 11004916 11004917 11004929 11004951 11004979 11004983 11004995 11004998 11004999 11005002 11005023 11005030 11005053 11005056 11005060 11005084 11005094 11005138 11005151 11005152 11005153 11005162 11005170 11005171 11005175 11005176 11005177 11005186 11005196…
FDA’s list runs to 46,285 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 46,285 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.