FDAClass IIIApril 4, 2018

STAGE-1¿ RDS COC Abutment Plastic Sleeve recall

STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Why was STAGE-1¿ RDS COC Abutment Plastic Sleeve recalled?

A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

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?

Lots: 35026, 35579, 36133

Product
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Recalling firm
Keystone Dental Inc
Quantity
55
Distribution
International Distribution to: Germany only.
Recall date
April 4, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls