Reported Jun 20, 2018 · Terminated
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or…
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?
- Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
- Lot codes and dates
- UDI
D76815737K0Lot 37038
- UDI
- Amount recalled
- 72
Where it was sold
Why it was recalled
The implants are mislabeled.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Keystone Dental Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.