FDAClass IIMay 10, 2017

6.8cm Controlled Depth Attachment Product Usage recall

6.8cm Controlled Depth Attachment Product Usage: Pneumatic system

Why was 6.8cm Controlled Depth Attachment Product Usage recalled?

Supplied Directions for Use (DFU) did not contain a recommended service interval.

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?

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0048; Part No. CDA.

Product
6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
Recalling firm
The Anspach Effort, Inc.
Quantity
4
Distribution
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Recall date
May 10, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls