VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented “” Total hip…
Medical device recall Z-0848-2016. 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
- 1305 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 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.”
1305, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item numbers: 00-7843-011-26 00-7843-011-56 00-7843-012-26 00-7843-012-56 00-7843-013-26 00-7843-013-56 00-7843-014-26 00-7843-014-56 00-7843-015-26 00-7843-015-46 00-7843-015-56 00-7843-016-26 00-7843-016-46 00-7843-016-56 00-7843-017-26…
Every code shown here, 1,992 characters
Item numbers: 00-7843-011-26 00-7843-011-56 00-7843-012-26 00-7843-012-56 00-7843-013-26 00-7843-013-56 00-7843-014-26 00-7843-014-56 00-7843-015-26 00-7843-015-46 00-7843-015-56 00-7843-016-26 00-7843-016-46 00-7843-016-56 00-7843-017-26 00-7843-017-46 00-7843-017-56 00-7843-018-26 00-7843-018-46 00-7843-018-56 00-7843-019-26 00-7843-019-46 00-7843-019-56 00-7843-020-26 00-7843-020-46 00-7843-020-56 00-7843-021-26 00-7843-021-46 00-7843-021-56 00-7843-022-26 00-7843-022-46 00-7843-022-56 lot numbers: 11003828 11004140 11004141 11004945 11005429 11005666 61633498 61699577 61704382 61710259 61710265 61721708 61735803 61735804 61735807 61735808 61735811 61741803 61741804 61741807 61746866 61752732 61757179 61757188 61759235 61759263 61759264 61759265 61760620 61768678 61768681 61769239 61775245 61775247 61781979 61781993 61781994 61786857 61786859 61786862 61807096 61815089 61829365 61829366 61834825 61840229 61840235 61840236 61840240 61840243 61844742 61844743 61848234 61848238 61848248 61852817 61852823 61876837 61879443 61879446 61879450 61884825 61884826 61884830 61902329 61902374 61902382 61910047 61910048 61910049 61910050 61910051 61910057 61910058 61915343 61915348 61920858 61920859 61920860 61932609 61932610 61932611 61937670 61937671 61937679 61937680 61946016 61946017 61946018 61946026 61956713 61956714 61956724 61963719 61963728 61974966 61993630 62003641 62003642 62003643 62003719 62006778 62011971 62025498 62025499 62025503 62025504 62025509 62029069 62034134 62043097 62043107 62045160 62053687 62053689 62053692 62054926 62054928 62067444 62067446 62071763 62071764 62077676 62077680 62077681 62085290 62085291 62085293 62085296 62089502 62089504 62089509 62097215 62097232 62097258 62097289 62097296 62102129 62107875 62107877 62107878 62116476 62116532 62132186 62132187 62133140 62135309 62135311 62135317 62135322 62143764 62143773 62147263 62147267 62153941 62153947 62158853 77000593 77000594 77000595 77000596 77000597 77000598 77000990 77001428…
FDA’s list runs to 2,036 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 2,036 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.