Arthrex 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.
FDA Recall Z-1206-2019 · Posted None
Recalling FirmArthrex, Inc.
Recall StatusTerminated
Product CodeGFF
Date Initiated2019-01-14
Date Terminated2023-08-31
Product Quantity2324
Reason for Recall
Devices may generate excessive heat during use.
Firm Action
On 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 [email protected]. 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 [email protected] 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 .
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Worldwide 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.