Reported May 7, 2014 · Terminated
The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and…
Acumed LLC
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: Acumed LLC · 5885 NW Cornelius Pass Rd · Hillsboro, OR · 97124-9432
Is this the product you have?
7 of 7 products
| Model / number | Product as published |
|---|---|
| — | The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin |
30-0097 | 70.0 mm Tension Band Pin |
30-0098 | 90.0 mm Tension Band Pin |
30-0099 | 50.0 mm Tension Band Kit |
TB-1550K-S | 70.0 mm Tension Band Kit |
TB-1570K-S | 90.0 mm Tension Band Kit |
TB-1590K-S | Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine. |
- Lot codes and dates
- 50.0
- mm Tension Band PinLot 243639 70.0
- mm Tension Band Pin
Lots 241127242707243325243948. 90.0
- mm Tension Band Pin
Lots 241128. 242708243327243949. 50.0
- mm Tension Band Kit
Lots 216769217002217941219145219402222732223007224312229889232575235490237772244800246204247056. 70.0
- mm Tension Band Kit
Lots 210290211349214574215405217004218273219230220978221503223008223477224066225554227193229394230287230952231971233742235502237773240512241185243617243945244801246777246779246938247108247109247493. 90.0
- mm Tension Band Kit
Lots 215053217005218600218700221465222731223009223756225555228951231573236969237774243620244802246939246990247381
- Amount recalled
- 2544 unit in the US and 3584 units outside the US
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.
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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