FDAClass IIAugust 5, 2015

ANSPACH - Fluted Drum recall: Labeling Error

ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.

Why was ANSPACH - Fluted Drum recalled?

G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.

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?

REF L-7DRC-G1 ; ALL lot numbers

Product
ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
Recalling firm
The Anspach Effort, Inc.
Quantity
115 tools.
Distribution
Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
Recall date
August 5, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls