FDA Enforcement
Class II
Terminated
MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Recall: Z-0756-2014
·
Reported January 22, 2014
Enforcement
- Recall Number
- Z-0756-2014
- Event ID
- 63624
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- The Anspach Effort, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 22, 2014
- Initiation Date
- March 29, 2012
- Classification Date
- January 14, 2014
- Termination Date
- March 11, 2015
- Address
- 4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235, United States
Description
MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Reason
The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide
Code Info
All lots are included in recall
Distribution
Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
Quantity
76