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U.S. Department of Health and Human Services

Class 2 Device Recall ARTHREX FRACTURE PLATES AND SCREWS; Low Profile Screw, cannulated AR89672865S

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  Class 2 Device Recall ARTHREX FRACTURE PLATES AND SCREWS; Low Profile Screw, cannulated AR89672865S see related information
Date Initiated by Firm June 24, 2020
Create Date July 29, 2020
Recall Status1 Terminated 3 on February 16, 2021
Recall Number Z-2733-2020
Recall Event ID 86021
510(K)Number K141478  
Product Classification Plate, fixation, bone - Product Code HRS
Product Sterile Low Profile Screw, Titanium, 6.7 x 65mm
Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
Code Information Batch Number: 10706233 UDI Number:00888867056411
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information Contact Arthrex Product Surveillance Department
866-297-9138
Manufacturer Reason
for Recall		 Screws provided in packaging are 5mm shorter than intended
FDA Determined
Cause 2		 Process control
Action Arthrex initiated recall on 06/24/2020. The notification states the following: 1 . Immediately discontinue use, sale, and distribution of the product. 2. Direct Customers (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or complaints@arthrex.de. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 3. Arthrex Subsidiaries (EMEA): a. Please contact Arthrex Product Surveillance at +49 89 9090 05 5240 or complaints@arthrex.de. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 4. Arthrex Subsidiaries (APAC): a. Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. Arthrex Product Surveillance Specialists are available to answer questions regarding credit for affected devices in your possession. b. You do not need to notify any patients of this product recall. 5. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com.
Quantity in Commerce 28 units
Distribution International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
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 = HRS and Original Applicant = ARTHREX, INC.
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