FDA-Device2014-07-02Class II
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
The Anspach Effort, Inc.
Hazard
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.
Sold states
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. .
Affected count
4
Manufactured in
4500 Riverside Drive, N/A, Palm Beach Gardens, FL, United States
Products
ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1875-2014Don't want to check this manually?
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