FDA Medical Device Recalls (openFDA)
Arthrex, Inc.: 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.
- Recall number
- Z-1206-2019
- Recalling firm
- Arthrex, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2019-01-14
- Posted
- not on file
- Terminated
- 2023-08-31
- Reason
- Devices may generate excessive heat during use.
- Root cause
- Unknown/Undetermined by 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 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
- 2324
- Distribution
- 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.
- Lot, serial or model codes
- Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFF
- Firm FEI
- 1220246
- Firm city
- Naples
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28