Reported Nov 2, 2016 · Terminated
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are…
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 · 154 Middlesex Tpke · Burlington, MA · 01803-4403
Is this the product you have?
- Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm
- Product code15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
- Lot codes and dates
- Lot # 27714
- Amount recalled
- 55 units
Where it was sold
Why it was recalled
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
This product could cause temporary or reversible health problems — stop using it.
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