Z-1206-2019Class II

Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft...

Name: Z-1206-2019 Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated for resection of soft...
Creator: Arthrex, Inc.
Published: 2019-01-14
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2019-01-14 / Terminated

FDA source

Arthrex, Inc. began a recall of 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... on 2019-01-14. FDA classified it as Class II and gives the reason as "Devices may generate excessive heat during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1206-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-14
Posted: 2019-04-23
Terminated: 2023-08-31
Recalling firm: Arthrex GmbH
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.
Product code: GFF Bur, Surgical, General & Plastic Surgery
Reason for recall: Devices may generate excessive heat during use.
FDA 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 [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 .
Quantity in commerce: 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.
Product codes and lots: Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1206-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1206-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-01	2019-04-23

Product code GFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)