FDA-Device2013-04-24Class II
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, an
Synvasive Technology Inc
Hazard
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Sold states
USA Nationwide Distributor including the state of IN
Affected count
100 kits
Manufactured in
4925 Robert J Mathews Pkwy, N/A, El Dorado Hills, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1127-2013Don't want to check this manually?
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