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U.S. Department of Health and Human Services

Class 2 Device Recall 13 cm Oval Burr

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 Class 2 Device Recall 13 cm Oval Burrsee related information
Date Initiated by FirmJanuary 14, 2019
Create DateApril 23, 2019
Recall Status1 Terminated 3 on August 31, 2023
Recall NumberZ-1206-2019
Recall Event ID 82009
Product Classification Bur, surgical, general & plastic surgery - Product Code GFF
ProductArthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft and osseous tissues in both large and small articular cavities during arthroscopic procedures.
Code Information Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023
FEI Number 1220246
Recalling Firm/
Manufacturer		 Arthrex, Inc.
1370 Creekside Blvd
Naples FL 34108-1945
For Additional Information ContactJerilyn J. Spencer
800-933-7001 Ext. 73293
Manufacturer Reason
for Recall		Devices may generate excessive heat during use.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn January 14, 2019, the firm, Arthrex, sent an "URGENT: VOLUNTARY PRODUCT RECALL NOTIFICATIONS" to all firms that received this device. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately discontinue use, sale, and distribution of the affected product 2. Direct customers: a) Please contact Arthrex Product Surveillance at 866-267-9138 or complaints@arthrex.com. Our 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 Agencies: a) Please contact FLS@arthrex.com as soon as possible to arrange for return of the affected product. b) You do not need to notify any customers as Arthrex will be notifying customers directly . 4. If you have any questions about this product recall, please contact Arthrex Product Surveillance at 866-267-9138 or complaints@art hrex.com .
Quantity in Commerce2324
DistributionWorldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, HI, IA, ID, IL, KY, LA, MA, MD, MI, MN, MO, NC, ND, NH, NY, OH, OK, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY; and to countries of: Germany, Brazil and Australia.
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.
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