FDAFDA · Food and drugs·Recall number Z-1127-2013
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Published April 24, 2013 · Recall initiated: March 14, 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
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synvasive Technology Inc
- Distributor
- USA Nationwide Distributor including the state of IN
- Lot
- Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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