—#136752

Product

ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K113476
Affected lot / code info: REF L-8DX-G1 ; ALL lot numbers

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions regarding this recall call 561-627-1080.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

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.

Timeline

Recall initiated: 2015-04-13
Posted by FDA: 2015-07-29
Terminated: 2016-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136752. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.