1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X…
Medical device recall Z-1042-2014. 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?
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT SCREW CRUCI 2.0 X 46 CORT SCREW CRUCI 2.0 X 48 CORT SCREW CRUCI 2.0 X 50 CORT SCREW CRUCI 2.7MM CORT. SCREW 6MM, ST 2.7MM CORT. SCREW 7MM, ST 2.7MM CORT. SCREW 8MM, ST 2.7MM CORT. SCREW 9MM, ST 2.7MM CORT. SCREW 10MM, S 2.7MM CORT. SCREW 12MM, S 2.7MM CORT. SCREW 14MM, S 2.7MM CORT. SCREW 16MM, S 2.7MM CORT. SCREW 18MM, S 2.7MM CORT. SCREW 20MM, S 2.7MM CORT. SCREW 22MM, S 2.7MM CORT. SCREW 24MM, S 2.7MM CORT. SCREW 26MM, S 2.7MM CORT. SCREW 28MM, S 2.7MM CORT. SCREW 30MM, S 2.7MM CORT. SCREW 32MM, S 2.7MM CORT. SCREW 34MM, S 2.7MM CORT. SCREW 36MM, S 2.7MM CORT. SCREW 38MM, S 2.7MM CORT. SCREW 40MM, S 2.7MM CORT. SCREW 42MM, S 2.7MM CORT. SCREW 44MM, S 2.7MM CORT. SCREW 45MM, S 2.7MM CORT. SCREW 46MM, S 2.7MM CORT. SCREW 48MM, S 2.7MM CORT. SCREW 50MM, S 2.7X52 CORT SCREW/SELFTAP 2.7X54 CORT SCREW/SELFTAP 2.7X55 CORT SCREW/SELFTAP 2.7X56 CORT SCREW/SELFTAP 2.7X58 CORT SCREW/SELFTAP 2.7X60 CORT SCREW/SELFTAP 2.7X65 CORT SCREW/SELFTAP 2.7X70 CORT SCREW/SELFTAP 3.5MM CORT. SCREW 10MM LN 3.5MM CORT. SCREW 12MM LN 3.5X14 CORT SCREW 3.5MM CORT. SCREW 14MM LN 3.5X16 CORT SCREW 3.5MM CORT. SCREW 16MM LN 3.5 X 16 SHAFT SCREW 3.5X18 CORT SCREW 3.5MM CORT. SCREW 18MM LN 3.5 X 18 SHAFT SCREW 3.5MM CORT. SCREW 20MM LN 3.5 X 20 SHAFT SCREW 3.5MM CORT. SCREW 22MM LN 3.5 X 22 SHAFT SCREW 3.5MM CORT. SCREW 24MM LN 3.5 X 24 SHAFT SCREW 3.5MM CORT. SCREW 26MM LN 3.5 X 26 SHAFT SCREW 3.5MM CORT. SCREW 28MM LN 3.5 X 28 SHAFT SCREW 3.5MM CORT. SCREW 30MM LN 3.5 X 30 SHAFT SCREW 3.5MM CORT. SCREW 32MM LN 3.5 X 32 SHAFT SCREW 3.5MM CORT. SCREW 34MM LN 3.5 X 34 SHAFT SCREW 3.5MM CORT. SCREW 36MM LN 3.5 X 36 SHAFT SCREW 3.5MM CORT. SCREW 38MM LN 3.5 X 38 SHAFT SCREW 3.5MM CORT. SCREW 40MM LN 3.5 X 40 SHAFT SCREW 3.5MM CORT. SCREW 45MM LN 3.5MM CORT. SCREW 50MM LN 3.5 X 50 SHAFT SCREW 3.5MM CORT. SCREW 55MM LN 3.5MM CORT. SCREW 60MM LN 3.5MM CORT. SCREW 65MM LN 3.5MM CORT. SCREW 70MM LN 3.5MM CORT. SCREW 75MM LN 3.5MM CORT. SCREW 80MM LN 3.5X85 CORT SCREW 3.5X90 CORT SCREW 3.5X95 CORT SCREW 3.5X100 CORT SCREW 3.5X105 CORT SCREW 3.5X110 CORT SCREW 3.5X115 CORT SCREW 3.5X120 CORT SCREW 3.5X125 CORT SCREW 3.5X130 CORT SCREW 3.5X135 CORT SCREW 3.5X140 CORT SCREW 3.5X145 CORT SCREW 3.5X150 CORT SCREW 4.0 X 10 CANCELL. SCREW 4.0 X 10 PART THD CANC SC 4.0 X 12 CANCELL. SCREW 4.0 X 12 PART THD CANC SC 4.0 X 14 CANCELL. SCREW 4.0 X 14 PART THD CANC SC 4.0 X 16 CANCELL. SCREW 4.0 X 16 PART THD CANC SC 4.0 X 18 CANCELL. SCREW 4.0 X 18 PART THD CANC SC 4.0 X 20 CANCELL. SCREW 4.0 X 20 PART THD CANC SC 4.0 X 22 CANCELL. SCREW 4.0 X 22 PART THD CANC SC 4.0 X 24 CANCELL. SCREW 4.0 X 24 PART THD CANC SC 4.0 X 26 CANCELL. SCREW 4.0 X 26 PART THD CANC SC 4.0 X 28 CANCELL. SCREW 4.0 X 28 PART THD CANC SC 4.0 X 30 CANCELL. SCREW 4.0 X 30 PART THD CANC SC 4.0 X 32 CANCELL. SCREW 4.0 X 34 CANCELL. SCREW 4.0 X 35 PART THD CANC SC 4.0 X 36 CANCELL. SCREW 4.0 X 40 CANCELL. SCREW 4.0 X 40 PART THD CANC SC 4.0 X 45 CANCELL. SCREW 4.0 X 45 PART THD CANC SC 4.0 X 50 CANCELL. SCREW 4.0 X 50 PART THD CANC SC 4.0 X 55 CANCELL. SCREW 4.0 X 55 PART THD CANC SC 4.0 X 60 CANCELL. SCREW 4.0 X 60 PART THD CANC SC 4.0 X 65 CANCELL. SCREW 4.0
7,044,680 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
61267037 61195515 61233513 61255911 61196113 61255912 61255913 61196115 61233517 61255914 61255915 61255916 61196121 61196122 61759822 61196123 61582530 61605810 61196124 61582531 61196125 61196126 61582532 61196127 61759823 61196128…
Every code shown here, 1,998 characters
61267037 61195515 61233513 61255911 61196113 61255912 61255913 61196115 61233517 61255914 61255915 61255916 61196121 61196122 61759822 61196123 61582530 61605810 61196124 61582531 61196125 61196126 61582532 61196127 61759823 61196128 61196129 61196131 61196132 61196133 61196134 61196460 61196461 61168863 61234474 61196462 61196463 61234476 61247538 61196464 61225322 61234477 61196465 61234479 61168867 61196466 61234480 61196467 61234481 61196468 61234482 61196469 61234484 61168870 61196470 61168871 61196471 61196472 61168873 61196473 61168874 61196474 61196475 61168875 61196476 61168876 61196477 60654904 61168877 61196478 61196479 60654906 61196480 61168878 61196482 61196483 61196484 61168880 61196485 61256597 61256599 61256600 61256601 61256603 61310792 61344225 61530374 61654821 61256605 61256606 61216613 61247253 61557215 61881416 61216616 61247255 61263780 61585001 61247492 61247493 61251362 61251363 61322883 61326924 61473762 61873515 61247496 61247272 61247273 61247275 61775835 61835769 61196225 61247504 61247505 61241617 61337168 61339774 61775836 61196226 61247277 61263781 61263782 61263783 61196227 61234462 61247278 61263784 61196228 61263785 61196229 61247280 61263786 61196230 61234465 61263787 61640844 61775837 61196231 60619377 61216644 61234466 61196232 61216646 61234467 61196233 61585002 61196234 61216649 61296496 61196235 60619404 61216651 61635840 61196236 61234469 61420532 61614769 61196237 61216653 61234470 61585003 61640846 61234471 61640847 61196239 60619379 61216656 60619382 60564048 60619380 61216659 61234473 60564052 60553867 60564055 60619373 60564056 60619372 61196212 61196213 61196214 61196215 61196216 61196217 61196218 61196219 61196220 61196221 61196222 61196223 61196224 61251335 61378853 61296498 61359796 61553346 61574969 61216664 61234486 61296499 61420534 61234487 61234488 61247467 61263788 61234489 61234491 61567476 61247468 61378854 61447036 61553315 61565530 61567477 61234505 61241624 61234494 61420533 61473763 61557223 61268670…
FDA’s list runs to 2,906 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 2,906 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.