Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile
Medical device recall Z-1883-2016. Published in FDA’s Enforcement Report on Jun 8, 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 Jun 8, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 3 states named in where it went
- 1110 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?
Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506 T14379, MTO35173505 T14380, MTO35175303 T8127.
1110, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
2743160001 6091900001 3035180001 NOT AVAILABLE 6245730001 6245740001 6245750001 6245760001 6245770001 6245780001 6245790001 6245800001 6245810001 6245820001 6245830001 6245840001 6245850001 6245860001 6245870001 6245880001 6245890001…
Every code shown here, 2,000 characters
2743160001 6091900001 3035180001 NOT AVAILABLE 6245730001 6245740001 6245750001 6245760001 6245770001 6245780001 6245790001 6245800001 6245810001 6245820001 6245830001 6245840001 6245850001 6245860001 6245870001 6245880001 6245890001 6245900001 6245910001 6245920001 6245930001 6245940001 6245950001 6245960001 6245970001 6245980001 6245990001 6246000001 6246010001 6246020001 6246030001 6246040001 6246050001 6246060001 6246070001 6246080001 6246090001 6246100001 6246110001 6246120001 6246130001 6246140001 6246150001 6246160001 6246170001 6246180001 6246190001 6246200001 6246210001 6246220001 6292870001 6420330001 6420340001 6422470001 6422480001 6422490001 6422500001 6422510001 6422520001 6422530001 6422540001 6422550001 6422560001 6441490001 6441500001 6448220001 6448230001 6448240001 6448250001 6448260001 6448270001 6448280001 6448290001 6448300001 6448310001 2091662 2091663 2091664 2091665 2091666 2091667 2091668 2091669 2091670 2091671 2091672 2091673 2091674 2091675 2091676 2091678 2091679 2091680 2091681 2091683 2091684 2091685 2091686 2091687 2091688 2091689 2091690 2091691 2091692 2091693 2091694 2091695 2091696 2091697 2091698 2091699 2091700 2091701 2091702 2091703 2091704 2091705 2091706 2091707 2091708 2091709 2091710 2091711 2091712 2169560 87437L01 87437L02 87437L03 87437L04 87437L05 87437L06 87437L07 87437L08 87437L09 87437L10 87437L11 87437L12 87437L13 87437L14 87437L15 87437L16 87437L17 87437L18 87437L19 87437L20 87437L21 87437L22 87437L23 87437L24 87437L25 87437L26 87437L27 87437L28 87437L29 87437L30 87437L31 87437L32 87437L33 87437L34 87437L35 87437L36 87437L37 87437L38 87437L39 87437l40 2367006 2367007 2367005 2367004 2367003 2367030 2367009 2367031 2367027 2367024 2367022 2367021 2367020 2367019 2367017 2367016 2367015 2367013 2367012 2367010 2367001 2366998 2366994 2366990 2366982 2366979 2366976 2366974 2366971 2366938 2366936 2366935 2366933 2366927 2366926 2366925 2366923 2366920 2366903 2366888 2461535 2461536 2461537 2461538 2461539 2461540…
FDA’s list runs to 2,513 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.
US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
The states and territories these words name
- Indiana
- Michigan
- Texas
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Apr 26, 2016.
- FDA classified it on Jun 1, 2016.
- FDA’s Enforcement Report published it on Jun 8, 2016.
- FDA terminated it on Jun 7, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Greatbatch Medical, of Plymouth, MN.
- 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 2,513 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.