CPT 12/14 COCR (various sizes)
Medical device recall Z-1032-2014. Published in FDA’s Enforcement Report on Feb 26, 2014.
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 Feb 26, 2014. 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
- 7,044,680 total 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?
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CPT 12/14 COCR (various sizes)
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60225078 60261757 60274775 60310767 60398002 60491038 60638468 60638470 60685165 60776190 60797319 60927586 61189804 61237349 61342952 61468762 61490103 61596784 61748948 61764725 61840597 61917999 61964635 61999588 62003977 60261761…
Every code shown here, 1,998 characters
60225078 60261757 60274775 60310767 60398002 60491038 60638468 60638470 60685165 60776190 60797319 60927586 61189804 61237349 61342952 61468762 61490103 61596784 61748948 61764725 61840597 61917999 61964635 61999588 62003977 60261761 60261763 60776227 60776234 60846362 60916726 60952935 60979483 61162865 61189800 61356814 61460831 61523005 61739387 61748949 61829563 61996730 60310780 60335521 60412478 60457571 60533531 60776287 60776288 60823773 60990055 61045309 61351320 61500146 61727738 61727739 61957411 60217292 60245136 60330281 60448728 60491098 60648441 60704737 60748770 60776312 60797325 60916737 60952946 61261797 61293863 61307997 61733348 61758312 61868121 61881187 61885896 61991679 62001331 60245153 60245154 60323912 60372490 60589471 60704749 60723802 60748790 60921196 60957269 61045290 61061843 61104280 61114610 61733350 61987756 61991676 60217518 60310793 60330358 60589477 60789763 60829712 60957183 60957252 61010390 61047782 61356826 61484547 61589156 61650372 61696379 61747548 61762055 61774068 61783714 61878465 61930415 61991684 61999776 62003973 62006549 62006552 62014206 60509163 61130729 61460829 61613256 61711999 62097052 60600577 60704770 60898905 61035924 61045315 61114612 61237346 61243405 61516824 61596779 61744474 61833302 61878466 61930418 61964629 60310799 60352497 60600588 60615058 60748834 60797333 60823790 60889814 60889815 60952953 60957186 60979502 61045316 61325399 61336846 61351344 61522157 61694927 61762060 61815831 62001327 60261985 60261986 60326340 60330332 60510215 60574913 60685247 60748844 60748850 60797335 60799614 60822508 60916748 60916749 60921201 60944305 61075599 61114637 61460856 61472388 61731627 61762053 61833303 61840602 61884450 61957405 62001329 60380023 60443946 60491173 60685261 60809480 61024361 61104288 61516832 61607601 60378595 60723862 60748854 60748855 60898910 61045291 61114614 61211994 61505499 61512550 61814507 61914812 61987765 60200828 60225125 60274811 60510226 60660270 60685253 60723871 60748857…
FDA’s list runs to 3,343 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-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
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 Oct 11, 2013.
- FDA classified it on Feb 20, 2014.
- FDA’s Enforcement Report published it on Feb 26, 2014.
- FDA terminated it on Apr 14, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, 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 3,343 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
-
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.