Reported Jun 8, 2016 · Terminated
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile.…
Greatbatch Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Greatbatch Medical · 2300 Berkshire Ln N · Plymouth, MN · 55441-4575
Is this the product you have?
- Torque Limiting ScrewdriverGreatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only
- ScrewdriverCustomer
- Number/Model
804-03-038 T11623T14001 T14001MTO35173507 T14378MTO375173506 T14379MTO35173505 T14380MTO35175303 T8127
- Lot codes and dates
- 2743160001 6091900001 3035180001 NOT AVAILABLE"05.1587814 05.1438412 05.1521913
268 of 268 codes
624573000162457400016245750001624576000162457700016245780001624579000162458000016245810001624582000162458300016245840001624585000162458600016245870001624588000162458900016245900001624591000162459200016245930001624594000162459500016245960001624597000162459800016245990001624600000162460100016246020001624603000162460400016246050001624606000162460700016246080001624609000162461000016246110001624612000162461300016246140001624615000162461600016246170001624618000162461900016246200001624621000162462200016292870001642033000164203400016422470001642248000164224900016422500001642251000164225200016422530001
- 2743160001 6091900001 3035180001 NOT AVAILABLE
- Amount recalled
- 1110
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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