ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Reported: July 2, 2014 Initiated: November 28, 2012 #Z-1915-2014
Product Description
ANSPACH***Arthroscopic Knotless Suture Anchor***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 their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 100
- 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. .
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems. Recalled by The Anspach Effort, Inc.. Units affected: 100.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1915-2014.
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