Device product
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.
Z-1127-2013
Product summary
- Event
- Event 64646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 kits
- Official record key
device-enforcement:Z-1127-2013
Official wording
Reason: Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Code information: Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
Distribution pattern: USA Nationwide Distributor including the state of IN
Derived failure modes
-
Unknown
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.