VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2…
Medical device recall Z-0849-2016. 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
- 4844 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?
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented “” Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. “ Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.”
4844, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-7843-011-06 00-7843-011-08 00-7843-011-36 00-7843-012-06 00-7843-012-08 00-7843-012-36 00-7843-013-06 00-7843-013-08 00-7843-013-36 00-7843-014-06 00-7843-014-08 00-7843-014-36 00-7843-015-06 00-7843-015-08 00-7843-015-36…
Every code shown here, 1,998 characters
Item numbers: 00-7843-011-06 00-7843-011-08 00-7843-011-36 00-7843-012-06 00-7843-012-08 00-7843-012-36 00-7843-013-06 00-7843-013-08 00-7843-013-36 00-7843-014-06 00-7843-014-08 00-7843-014-36 00-7843-015-06 00-7843-015-08 00-7843-015-36 00-7843-016-06 00-7843-016-08 00-7843-016-36 00-7843-017-06 00-7843-017-08 00-7843-017-36 00-7843-018-06 00-7843-018-08 00-7843-018-36 00-7843-019-06 00-7843-019-36 00-7843-020-06 00-7843-020-08 00-7843-020-36 00-7843-021-06 00-7843-021-36 00-7843-022-06 00-7843-022-36 Lot numbers: 11003968 11003975 11004089 11004219 11004274 11004333 11004746 11005067 11005118 11008034 61669552 61669554 61669559 61669561 61669563 61695978 61699465 61704396 61704397 61714436 61721717 61721719 61721720 61729915 61729916 61729917 61729919 61735802 61735816 61735817 61735818 61741801 61741802 61741815 61746858 61746859 61746860 61746875 61746876 61746878 61746888 61746890 61746892 61752717 61752718 61752719 61752722 61752738 61752739 61752740 61759256 61759257 61759271 61759272 61759273 61759274 61759275 61759276 61768675 61768676 61768677 61768689 61768690 61768691 61768692 61768693 61768695 61768696 61768697 61768698 61768699 61775242 61775243 61775251 61775252 61775253 61775254 61781978 61781998 61781999 61782001 61782002 61786858 61786866 61786867 61792530 61792544 61792545 61792546 61792547 61792561 61797304 61797305 61797306 61797307 61797308 61797309 61797310 61797311 61797312 61797314 61797315 61797316 61797317 61797318 61797319 61797320 61797321 61797322 61797323 61803226 61803227 61803229 61803230 61803231 61803233 61807094 61807095 61807106 61807107 61807108 61807109 61807110 61807111 61807112 61807113 61807114 61813331 61813332 61813336 61813345 61813352 61813353 61813356 61813363 61813364 61813367 61813369 61813370 61813371 61813372 61813373 61813374 61814011 61814012 61814013 61814014 61814015 61814016 61814017 61814018 61814019 61814020 61814021 61814022 61814023 61815074 61815075 61815077 61815078 61815096 61815098 61829335 61829338…
FDA’s list runs to 6,291 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 6,291 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.