ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended...
FDA Recall #Z-1875-2014 — Class II — November 28, 2012
Product Description
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
Reason for Recall
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.
Recalling Firm
The Anspach Effort, Inc. — Palm Beach Gardens, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4
Distribution
Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
Code Information
Part Numbers: 98-0006, 98-0009. Serial Numbers: 20030001, 20030002 20033501, 20033502.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated