Z-2839-2016Class II

G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium

Name: Z-2839-2016 G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium
Creator: The Anspach Effort, Inc.
Published: 2016-08-26
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2016-08-26 / Terminated / root cause: design

FDA source

The Anspach Effort, Inc. began a recall of G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium on 2016-08-26. FDA classified it as Class II and gives the reason as "The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2839-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-26
Posted: 2016-09-16
Terminated: 2017-11-29
Recalling firm: The Anspach Effort, Inc.
Product: G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 63
Distribution: AZ, DC, CA, MD, MI, and OR Switzerland
Product codes and lots: Material M-3SB-2-G1 Batch J316017640

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2839-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2837-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-16
Z-2838-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-16
Z-2839-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-16
Z-2840-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-16

Product code HBE

K113476Class IIAnspach Dissection ToolsThe Anspach Effort, Inc. / cleared 2011-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)