FDA-Device2014-07-02Class II
ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***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 their Anspach Custom Devices. The units were not manufactured consistently 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
1
Manufactured in
4500 Riverside Drive, N/A, Palm Beach Gardens, FL, United States
Products
ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***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-1876-2014Don't want to check this manually?
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