The Anspach Effort, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0783-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 5, 2012

Date Posted: February 13, 2013

Recall Number: Z-0783-2013

Event ID: 63793

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.

Status: Terminated

Product Quantity: 8 devices

Code Information:

Lot number: 2000930

Distribution Pattern:

Distributed in the state of Massachusetts

Voluntary or Mandated:

Voluntary: Firm initiated