Reported Apr 24, 2013 · Terminated
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4,…
Synvasive Technology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synvasive Technology Inc · 4925 Robert J Mathews Pkwy · El Dorado Hills, CA · 95762-5701
Is this the product you have?
- The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH
- Product UsageFor 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
- Lot codes and dates
- Biomet Product code
506076Lot 829182
- Synvasive Part Number11-3629
- Biomet Product code
- Amount recalled
- 100 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- IN
Why it was recalled
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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