Reported Jun 1, 2016 · Terminated
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits…
Synthes (USA) Products LLC
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: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 3.2 mm three-fluted Radiolucent Drill Bit/Needle
- Point/145 mm Sterile Product UsageThe 3.2 mm Three-fluted Drill Bits are instruments that
- can be used with the following systemsExpert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN)
- Lot codes and dates
Catalog ID 03.010.100S Lot # 552587261533686530901554870761973156581051 557591861992326676406560346362318506721724 564911762565606734876566888063058426808463 572463963190506831468574227663201506997294 580734163439807039877601277064018197052565 604559764487077081479605791464721007378832 610834265018567410311614244365033517466207 755467076209717675571771169478012517918026 9815103982893299058509939769H033348
- Amount recalled
- 1274 units
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
Why it was recalled
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
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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