Z-2285-2015 Class II Terminated

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-2285-2015 was initiated by The Anspach Effort, Inc. on Apr 13, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Aug 25, 2016). Affected quantity: 115 tools.

Recall Details

Product Type
Devices
Report Date
Aug 5, 2015
Initiation Date
Apr 13, 2015
Termination Date
Aug 25, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
115 tools.

Product Description

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

Reason for Recall

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.

Distribution Pattern

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.

Code Information

REF L-7DRC-G1 ; ALL lot numbers

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2285-2015
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.