Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection too

FDA device recall Z-0783-2013 · posted 2013-02-04 · Terminated

Recall details

Recalling firm

The Anspach Effort, Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HTT

Quantity affected

8 devices

Distribution

Distributed in the state of Massachusetts

Date initiated

2012-09-05

Date posted

2013-02-04

Date terminated

2014-08-13

Location

Palm Beach Gardens, FL