Recall Z-1206-2019
Arthrex, Inc. · initiated January 14, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Numbers: 10211276 (expiration date: 4/30/2023 and 10202784 (expiration date: 3/31/2023
Reason for recall
Devices may generate excessive heat during use.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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 .
Details
- Recall number
- Z-1206-2019
- Initiated
- January 14, 2019
- Terminated
- August 31, 2023
- Product code
- GFF – Bur, Surgical, General & Plastic Surgery
- 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.
- Recalling firm
- Arthrex, Inc., Naples, FL