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Terminated

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.

FDA Recall Z-0783-2013 · Posted 2013-02-04

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHTT
Date Initiated2012-09-05
Date Terminated2014-08-13
Product Quantity8 devices

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in the state of Massachusetts

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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