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U.S. Department of Health and Human Services

Class 2 Device Recall Bearing Sleeve with Removable Bur Guard

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 Class 2 Recall
Bearing Sleeve with Removable Bur Guard
see related information
Date Posted February 04, 2013
Recall Status1 Terminated on August 13, 2014
Recall Number Z-0783-2013
Recall Event ID 63793
Product Classification Burr, Orthopedic - Product Code HTT
Product 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.
Code Information Lot number: 2000930
Recalling Firm/
Manufacturer
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens, Florida 33410-4235
For Additional Information Contact Jessica Smith
561-627-1080
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action 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 8 devices
Distribution 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.
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