| Class 2 Device Recall Anspach Modified MDA Tube with MAD20 Attachment | |
Date Initiated by Firm | November 28, 2012 |
Date Posted | June 25, 2014 |
Recall Status1 |
Terminated 3 on August 07, 2014 |
Recall Number | Z-1888-2014 |
Recall Event ID |
64247 |
510(K)Number | K080802 |
Product Classification |
Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
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Product | ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only***
This device is intended to be used with Anspach Systems |
Code Information |
Part Number: 98-0019; Serial Number: 200422 |
Recalling Firm/ Manufacturer |
The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens FL 33410-4235
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For Additional Information Contact | Suzanne Goodman 561-494-3706 |
Manufacturer 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. |
FDA Determined Cause 2 | Process design |
Action | The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887.
For questions regarding this recall call 561-494-3706. |
Quantity in Commerce | 1 |
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.
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Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HBE
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