Recalls / —

—#149408

Product

G1 Dissection Tool - 3mm FLUTED BALL; For cutting and 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

Material M-3SB-2-G1 Batch J316017640

Why it was recalled

The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.

Root cause (FDA determination)

Device Design

Action the firm took

On April 26, 2016 DePuy Synthes sent a letter informing their customers of the recall. ACTION REQUIRED Our records show that your facility has received one or more of product(s) subject to the recall (correction). The Anspach Effort, Inc. asks that you: 1) There is no requirement for retaining your inventory of Gl Dissection Tools. 2) To ensure Gl Cutting Tool & Attachment compatibility, please reference Table 1 to review which Attachments are compatible. The Cutting TooVAttachment combination noted with a check mark in Table I will function as intended. The Cutting Tool/Attachment combinations noted with an "X" in Table 1 will not secure effectively and should not be used. 3) Review, complete, sign and return the attached reply form confirming your receipt of this letter by fax or email details provided on the form. Returning the form promptly will prevent you from receiving repeat notices. 1. Share this letter with others in your facility that needs to be made aware of this recall (correction). 2. If you distribute any of the product(s) subject to the recall (correction) to other services or facilities, please forward this letter as appropriate immediately. 3. Keep a copy of this notice with the product(s) subject to the recall (correction). If you have any questions regarding this correction, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.

Recalling firm

Firm

The Anspach Effort, Inc.

Address

4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern

AZ, DC, CA, MD, MI, and OR Switzerland

Timeline

Recall initiated

2016-08-26

Terminated

2017-11-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #149408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.