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U.S. Department of Health and Human Services

Class 2 Device Recall Cannulated Drill bit 2.0mm and 2.6 mm

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  Class 2 Device Recall Cannulated Drill bit 2.0mm and 2.6 mm see related information
Date Initiated by Firm December 22, 2016
Create Date January 28, 2017
Recall Status1 Terminated 3 on November 27, 2017
Recall Number Z-1113-2017
Recall Event ID 76156
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Code Information Device Listing: D267957
Recalling Firm/
Manufacturer		 Flower Orthopedics Corporation
100 Witmer Rd Ste 280
Horsham PA 19044-2647
For Additional Information Contact
215-394-8903
Manufacturer Reason
for Recall		 The product is being recalled due to incidence and reports of the product breaking during surgery.
FDA Determined
Cause 2		 Device Design
Action Flower Orthopedics mailed a letter to customers on December 22, 2016 making them aware of the issue. Customers were asked to return the affected product and to report if any adverse effects resulted from its use.
Distribution Distributed throughout the United States
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.
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