Naples, FL, United States
Arthrex, Inc. recalls
12 recalls recorded since 2018, most recently on 2 November 2022. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls12
Ongoing (FDA)5
Terminated or completed7
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 November 2022
- Reason
- The devices may be packaged with the wrong reamer size.
- Distribution
- Distribution was made to AL, AR, CA, CO, FL, IA, IL, LA, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TX, UT, and VA. There was no military/government distribution. Foreign distribution was made to Ecuador, Germany, Russia, Canada, China, Finland, France, Germany, Portugal, and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0465-2023
- Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-8981-08S, 8mm, both containing a cannulated reamer, sterile.
Terminated Class II Medical devices
- Recall started
- 25 March 2022
- Terminated
- 15 May 2026
- Reason
- Products do not meet length and diameter specifications.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of OH, TN, MO, LA, IA, AZ, PA, NY, OR and the countries of to Belgium, Egypt, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1035-2022
Ongoing Class II Medical devices
- Recall started
- 14 June 2021
- Reason
- Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
- Distribution
- US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2107-2021
- Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Terminated Class II Medical devices
- Recall started
- 11 March 2021
- Terminated
- 29 October 2024
- Reason
- It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1380-2021
- Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Terminated Class II Medical devices
- Recall started
- 24 February 2021
- Terminated
- 2 May 2023
- Reason
- The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
- Distribution
- US Nationwide distribution in the states of Ohio, Oregon, Tennessee, Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1310-2021
- Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of foot and ankle procedures.
Terminated Class II Medical devices
- Recall started
- 24 June 2020
- Terminated
- 16 February 2021
- Reason
- Screws provided in packaging are 5mm shorter than intended
- Distribution
- International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2733-2020
- Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, f
Terminated Class II Medical devices
- Recall started
- 17 December 2019
- Terminated
- 31 August 2023
- Reason
- There is a potential for blockage of the Hub Attachment Tube.
- Distribution
- Nationwide in US; no distribution OUS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0919-2020
- Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide
Terminated Class II Medical devices
- Recall started
- 1 October 2019
- Terminated
- 8 September 2021
- Reason
- Screws provided in the device package are 6 mm longer than intended.
- Distribution
- US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1510-2020
- Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
Terminated Class II Medical devices
- Recall started
- 14 January 2019
- Terminated
- 31 August 2023
- Reason
- Devices may generate excessive heat during use.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1206-2019
- 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.
Ongoing Class II Medical devices
- Recall started
- 19 November 2018
- Reason
- Potentially lead to anchor breakage during insertion,
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Finland and Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0724-2019
- Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wris
Ongoing Class II Medical devices
- Recall started
- 13 September 2018
- Reason
- There is potential to break during use.
- Distribution
- Distributed throughout the U.S. to the following states: NC, CA, NJ, CO, NV, UT, LA, KY, OH, AZ, MO, MN, TN, NY, WI, MA, PA, TX, IL, PA, AR, FL, IA, MI, AL, SD, OR, WA, MD, KS, and GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0442-2019
- 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains instrumentation for the implantation of the FibuLock implant. Contents include: A
Ongoing Class II Medical devices
- Recall started
- 27 August 2018
- Reason
- The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
- Distribution
- Worldwide - Nationwide Distribution in the states of AL, CA, CO, FL, ID, IL, MA, MD, MI, MO, NC, NE, NY, PA, SC, TN, TX, UT, WI. and the countries of Austria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Italy, Kuwait, Lithuania, Netherlands, No
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0295-2019
- Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.