||February 04, 2013
||Terminated on August 13, 2014
|Recall Event ID
Burr, Orthopedic -
||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
|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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.