ONE-PIECE LAG SCREW 11MM
Medical device recall Z-1014-2014. 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?
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
60068459 60152928 60198635 60254679 60393366 60550119 60604063 60630562 60654332 60688667 60705395 60804579 61238538 60137582 60155302 60198636 60338337 60435949 60550120 60604064 60630563 60664392 60705397 61034009 60154177 60155303…
Every code shown here, 1,993 characters
60068459 60152928 60198635 60254679 60393366 60550119 60604063 60630562 60654332 60688667 60705395 60804579 61238538 60137582 60155302 60198636 60338337 60435949 60550120 60604064 60630563 60664392 60705397 61034009 60154177 60155303 60172595 60203125 60208505 60293052 60293053 60385452 60435952 60451975 60513716 60550121 60569137 60621316 60653000 60671936 60690725 60700503 60783464 60820534 60860511 60860513 60860514 60922581 60931393 61057541 61057542 61091712 61144231 61144232 61175725 61179682 61213680 61213685 61226623 61458924 61496585 61496586 61516718 61652312 61987298 60931393R 60068461 60085970 60112862 60137583 60167084 60177165 60203127 60208506 60230633 60254680 60263992 60281385 60293054 60323227 60323228 60338339 60351950 60363732 60381044 60381045 60429147 60451979 60472802 60488988 60513720 60536838 60544315 60550122 60550123 60569139 60585209 60604065 60604067 60646729 60671937 60671938 60700504 60705398 60736738 60736739 60783465 60804583 60804584 60820535 60820536 60879653 60879654 60879655 60922582 60973810 61004373 61057265 61057267 61057528 61083833 61083835 61086989 61110816 61133147 61133148 61133149 61144233 61144234 61168198 61168199 61179683 61196070 61209047 61213689 61226624 61226625 61251155 61346007 61352916 61359836 61371148 61392581 61466852 61508368 61524260 61524261 61584950 61612575 61639615 61657718 61746169 61781850 61890428 61930475 61987301 62070014 62070016 62133640 60569139R 60700504R 61144234R 60063005 60106621 60111972 60132528 60137584 60155304 60167085 60172596 60177167 60186862 60198526 60198637 60218946 60218947 60218948 60242254 60245527 60254681 60263994 60263995 60281387 60293055 60293056 60309898 60309899 60323229 60323230 60338340 60338341 60363733 60367337 60367338 60381046 60381047 60385453 60393368 60423609 60425113 60435972 60435975 60451981 60451982 60472803 60479109 60487347 60488989 60513721 60528722 60536839 60536840 60550124 60569140 60569141 60576790 60585211 60585212 60597782 60604069 60604071…
FDA’s list runs to 9,964 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 9,964 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.