Reported Jun 8, 2016 · Terminated
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting…
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 AdapterTorque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile
- Customer Number/Model
00-2360-080-00 T10232T116245 T116245TLA025-25 TLA025-2500-2360-080-05 T10233MAC21003 T116430TLA025-30 TLA025-30MAC21001 T112972MAC21001 T13621TLA025-20 TLA025-20
- Lot codes and dates
106 of 106 codes
100020710010491001048100069810005821000582100133410013341002457100245610029741002640100317510031741003223100322310032241003225100354810037661003908100443510044851004349100490310050991004347100553010057721005900100901310084581009195100919510091971009014100919810091961009698100919910096991009200100970010117631010602101245510124901013172101317310134151013416101392110139221514611161460517147001953758195380919538102124866
- Amount recalled
- 5952
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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