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.
Recall
- Recall Number
- Z-1127-2013
- Event Number
- 64646
- Firm
- Synvasive Technology Inc
- FEI Number
- 1000123893
- Product Code
- HSD
- Status
- Terminated
- Root Cause
- Packaging change control
- Initiated
- March 14, 2013
- Posted
- April 17, 2013
- Terminated
- January 13, 2014
- Address
- 4925 Robert J Mathews Pkwy, El Dorado Hills, CA, 95762-5701
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.
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
An Urgent Medical Device Recall Notice letter dated March 21, 2013 was sent to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use; remove the products from inventory and complete and return the attached Response Form. For questions call 574-372-1570.
USA Nationwide Distributor including the state of IN
100 kits