G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium.
FDA Recall Z-2839-2016 · Posted None
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Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBE
Date Initiated2016-08-26
Date Terminated2017-11-29
Product Quantity63
Reason for Recall
The firm discovered on March 4, 2016 that several product codes were inadvertently left off of Hold 1503.
Firm 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.
Root Cause
Device Design
Distribution Pattern
AZ, DC, CA, MD, MI, and OR Switzerland
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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