Reported Mar 27, 2013 · Terminated
PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed…
Keystone Dental 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: Keystone Dental Inc · 144 Middlesex Tpke · Burlington, MA · 01803-4403
Is this the product you have?
- PrimaConnex Tapered Implant TC, SD Internal Connection 3.5
- x 10mm Catalog Numberl5613K. Implants in support for fixed bridgework
- Lot codes and dates
- Lot Number12857
- Amount recalled
- 120 units
Where it was sold
Why it was recalled
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
This product could cause temporary or reversible health problems — stop using it.
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