NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee,…
Medical device recall Z-0831-2016. 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
- 42064 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 CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer 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.”
42064, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-5950-012-01 00-5950-012-02 00-5950-013-01 00-5950-013-02 00-5950-013-05 00-5950-013-06 00-5950-014-01 00-5950-014-02 00-5950-014-05 00-5950-014-06 00-5950-015-01 00-5950-015-02 00-5950-015-05 00-5950-015-06 00-5950-016-01…
Every code shown here, 1,998 characters
Item numbers: 00-5950-012-01 00-5950-012-02 00-5950-013-01 00-5950-013-02 00-5950-013-05 00-5950-013-06 00-5950-014-01 00-5950-014-02 00-5950-014-05 00-5950-014-06 00-5950-015-01 00-5950-015-02 00-5950-015-05 00-5950-015-06 00-5950-016-01 00-5950-016-02 00-5950-016-05 00-5950-016-06 00-5950-017-01 00-5950-017-02 00-5950-017-05 00-5950-017-06 00-5952-012-01 00-5952-012-02 00-5952-013-01 00-5952-013-02 00-5952-013-05 00-5952-013-06 00-5952-014-01 00-5952-014-02 00-5952-014-05 00-5952-014-06 00-5952-015-01 00-5952-015-02 00-5952-015-05 00-5952-015-06 00-5952-016-01 00-5952-016-02 00-5952-016-05 00-5952-016-06 00-5952-017-01 00-5952-017-02 00-5952-017-05 00-5952-017-06 00-5956-012-01 00-5956-012-02 00-5956-013-01 00-5956-013-02 00-5956-013-05 00-5956-013-06 00-5956-014-01 00-5956-014-02 00-5956-014-05 00-5956-014-06 00-5956-015-01 00-5956-015-02 00-5956-015-05 00-5956-015-06 00-5956-016-01 00-5956-016-02 00-5956-016-05 00-5956-016-06 00-5956-017-01 00-5956-017-02 00-5956-017-05 00-5956-017-06 Lot numbers: 11003331 11003479 11004184 11004653 11004819 11004864 11004891 11004997 11005134 11005150 11005197 11005206 11005279 11005343 11005424 11005628 11005673 11005698 11005702 11005794 11005844 11005855 11005857 11005897 11005937 11005939 11005982 11006036 11006046 11006061 11006062 11006063 11006070 11006106 11006198 11006211 11006214 11006272 11006310 11006376 11006438 11006476 11006477 11006485 11006525 11006589 11006590 11006594 11006651 11006717 11006799 11006813 11006891 11006943 11006976 11007101 11007410 11007427 11400110 11400113 11400131 11400138 11400146 11400150 11400155 11400160 11400162 11400169 11400174 11400179 11400180 11400181 11400183 11400195 11400206 11400231 11400236 11400241 11400250 11400251 11400257 11400258 11400260 11400281 11400293 11400355 11400361 11400365 11400369 11400370 11400371 11400372 11400376 11400377 11400378 11400379 11400384 11400388 11400390 11400391 11400393 11400394 11400397 11400403 11400404 11400406 11400409 11400413 11400414…
FDA’s list runs to 20,513 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 20,513 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.