M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM
Medical device recall Z-1007-2014. 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?
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
368278 61111052 61159202 61228030 61276758 61307948 61111052R 368279 60275442 60994837 61111053 61255583 61294523 61556944 368280 61098707 61178911 61284930 61298508 61342119 61546150 60158048 60281123 61075888 61159203 61220139 61290248…
Every code shown here, 1,998 characters
368278 61111052 61159202 61228030 61276758 61307948 61111052R 368279 60275442 60994837 61111053 61255583 61294523 61556944 368280 61098707 61178911 61284930 61298508 61342119 61546150 60158048 60281123 61075888 61159203 61220139 61290248 61332792 61727932 368490 60158049 60506370 60741224 60960320 61111054 61120925 61143374 61220140 61298509 61143374R 368281 60114142 60232597 60518286 60960628 60960818 61220141 61266215 61281313 61317747 60175525 60281124 60958453 60960815 61140792 61159204 61275565 61317749 60960815R 61275565R 368311 368493 60082894 60281333 61075889 61111055 61159205 61220142 61290251 61338952 368112 368494 60186975 60253467 60703526 60994877 61075890 61111056 61143376 61220143 61275566 60186975R 60253467R 60703526R 368284 368285 368948 60082895 60186976 60305055 60958452 60960816 61140794 61271223 61281317 61313785 367853 368496 60376357 60506371 60725289 61075891 61140795 61237562 61281322 61298511 61468151 60506371R 60725289R 368324 368497 60082896 60484441 61020656 61075892 61117767 61220144 61294524 61501046 00368497R 60082896R 368286 368498 60158050 60484442 60718439 61237563 61266214 61294525 61367353 00368498R 60158050R 60484442R 60718439R 61266214R 368287 60186977 61140796 61267607 61290253 61341154 00368287R 60186977R 61140796R 368288 60186978 61178912 61307949 61501047 00368500R 60186978R 61178912R 61501047R 368312 61178913 61317751 61328162 61317751R 368313 60186979 61143378 61211142 61228027 61290256 61328163 00368313R 61211142R 61290256R 368289 60158051 60919031 61275568 00368289R 60158051R 368113 60165694 60677567 60919032 61117768 61140797 61317753 61338953 61428547 367341 368114 60591981 61075893 61117769 61140799 61155653 61237564 61249763 61281323 61453188 61501049 61249763R 61501049R 368115 60591982 61049751 61075894 61114076 61140801 61206020 61214454 61220913 61290257 61501052 61049751R 367183 367833 60214950 60338296 60771516 60931843 61075895 61114077 61117770 61140802 61155654 61214458 61220922 60771516R 368116 60114143…
FDA’s list runs to 14,634 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 14,634 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.