Z-1127-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2013
- Initiation Date
- March 14, 2013
- Termination Date
- January 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100 kits
Product Description
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.
Reason for Recall
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Distribution Pattern
USA Nationwide Distributor including the state of IN
Code Information
Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.