|Date Initiated by Firm
||September 05, 2012
|Date Posting Updated
||February 04, 2013
||Terminated 3 on August 13, 2014
|Recall Event ID
||Burr, Orthopedic - Product Code HTT
||Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
||Lot number: 2000930
| The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
|For Additional Information Contact
between the bur and bur guard could generate metal fragments that may or may not be visible to the
surgeon and can potentially remain in the surgical site.
The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.
||The firm, Anspach Effort, Inc. sent an "URGENT: Medical Device Removal" letter dated November 7, 2012, to its customer. The letter identified the product, problem and actions to be taken.
The customer was instructed to do the following: 1) Screen their inventory and remove and return all products immediately. 2) Complete and return the attached Customer Reply Form via fax or email to the address provided on the form.
Should the customer have any questions, please contact Anspach Product Support at (800) 327-6887.
|Quantity in Commerce
||Distributed in the state of Massachusetts
|Total Product Life Cycle
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.