FDAClass IIMarch 7, 2018

Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single recall: Labeling Error

Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous…

Why was Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single recalled?

The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog# S2400K, Lot 34276

Product
Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous…
Recalling firm
Keystone Dental Inc
Quantity
20
Distribution
Nationally.
Recall date
March 7, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls