—#114783

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.

FDA product code: HTT — Burr, Orthopedic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot number: 2000930

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: Distributed in the state of Massachusetts

Timeline

Recall initiated: 2012-09-05
Posted by FDA: 2013-02-04
Terminated: 2014-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114783. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.