| Class 2 Device Recall Anspach REF: TURQ4344 Twist Drill for 1.5mm x 4mm screw. | |
Date Initiated by Firm | March 31, 2011 |
Date Posted | January 27, 2014 |
Recall Status1 |
Terminated 3 on July 18, 2019 |
Recall Number | Z-0830-2014 |
Recall Event ID |
67176 |
510(K)Number | K011444 K974025 |
Product Classification |
Motor, drill, electric - Product Code GFF
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Product | Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only
Single use Sterile bone cutting burs. |
Code Information |
Lot #'s: D323038131 and D343038845 |
Recalling Firm/ Manufacturer |
The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens FL 33410-4235
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For Additional Information Contact | Customer Service 800-327-6887 |
Manufacturer Reason for Recall | Cutter was longer than was stated on the label |
FDA Determined Cause 2 | Pending |
Action | Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887.
For questions regarding this recall, call 800-327-6887. |
Quantity in Commerce | 29 cutting burs |
Distribution | Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany. |
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 = GFF
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