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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 AR89672865Ssee related information
Date Initiated by FirmJune 24, 2020
Create DateJuly 29, 2020
Recall Status1 Terminated 3 on February 16, 2021
Recall NumberZ-2733-2020
Recall Event ID 86021
510(K)NumberK141478 
Product Classification Plate, fixation, bone - Product Code HRS
ProductSterile 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
FEI Number 1220246
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information ContactArthrex 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
ActionArthrex 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 Commerce28 units
DistributionInternational distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HRS
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