FDAFDA · Food and drugs·Recall number Z-1061-2013
Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex France The Baseplate Impactor Extractor is intended to securely attach to the tibial baseplate or baseplate trial for impaction and extraction during surgery.
Published April 17, 2013 · Recall initiated: February 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- Worldwide Distribution - USA (nationwide) and internationally to Canada, Japan, Australia, China, New Zealand, France, Italy, Netherlands, Poland, Spain, Sweden, Switzerland and the United Kingdom.
- Lot
- Catalog Number 6541-4-805. Lot Numbers: RD4V204; RD5V234; RD5V235; RD5V235A; RD5V235Y; RD5V236; RD5V236A; RD5V237; RD6A009; RD6A010; RD6A011; RD6A011P; RD6A012; RD6A051; RD6A052; RD6A053; RD6A053M; RD6A053T; RD6A061; RD6A061A; RD6A062; RD6A062N; RD6A063; RD6A063T; RD6A065; RD6A065D; RD6A065T; RD6A066; RD6A066A; RD6C103; RD6C103L; RD6C104; RD6C104Y; RD6C105; RD6C105M; RD6C105T; RD6C106; RD6C106A; RD6C108; RD6C109; RD6C109L; RD6C126; RD6H178; RD6H184; RD6H187; RD6L222; RD6L223; RD6L223A; RD6L224; RD6L224A; RD6L226; RD6L227; RD6L227A; RD6L227N; RD6M148; RD6M158; RD6M159; RD6M161; RD6M163; RD6M163A; RD6M163L; RD6M164; RD6M164A; RD6M165; RD6N046; RD6N046L; RD6N047; RD6N047N; RD6N048; RD6N052; RD6N052T; RD6N053; RD6N054; RD6N072; RD6N072H; RD6N073; RD6N074; RD6N074J; RD6N158; RD6N159; RD6N160; RD6S054; RD6S055; RD6S055A; RD6S056; RD6S081; RD6S082; RD6S082Y; RD6S083; RD6S083Y; RD6S084; RD6S084A; RD6S085; RD6S085Y; RD6S142; RD6S142Y; RD6S143; RD6S143A; RD6S144; RD6S144Y.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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