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U.S. Department of Health and Human Services

Class 2 Device Recall Anspach 8 mm Coarse Threaded Headless Bone Screw

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  Class 2 Device Recall Anspach 8 mm Coarse Threaded Headless Bone Screw see related information
Date Initiated by Firm November 28, 2012
Date Posted June 25, 2014
Recall Status1 Terminated 3 on August 07, 2014
Recall Number Z-1878-2014
Recall Event ID 64247
510(K)Number K080802  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only***

This device is intended to be used with Anspach Systems
Code Information Part Number 98-0029; Serial Number: 20000263
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
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 10
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. .
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = HBE and Original Applicant = THE ANSPACH EFFORT, INC.
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