FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
- Recall number
- Z-2839-2016
- Recalling firm
- The Anspach Effort, Inc.
- Product
- G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
- Status
- Terminated
- Initiated
- 2016-08-26
- Posted
- not on file
- Terminated
- 2017-11-29
- Reason
- The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
- 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
- 63
- Distribution
- AZ, DC, CA, MD, MI, and OR Switzerland
- Lot, serial or model codes
- Material M-3SB-2-G1 Batch J316017640
- 510(k) numbers
- ["K113476"]
- PMA numbers
- not on file
- Product code
- HBE
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28