Austin, TX, United States
ArthroCare Corporation recalls
2 recalls recorded since 2018, most recently on 17 August 2020. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 17 August 2020
- Reason
- Due to a supplier error where a portion of the raw material was inadvertently mixed. As a result, some needles may be made of commercially pure titanium as opposed to 304 stainless steel which does not meet the specification and could potentially break during use.
- Distribution
- Domestic Distribution: AK, AL, AR, AZ, CA, CO, CT,DB,FL,GA, HI, IA, ID, IL, IN, KS, KY, MA,MD,ME,MI,MN,MO,MS,MT, NC,ND, NE, NJ, NSW, NV,NY, OH,OK, OR, PA,SC, TN,TX, UT, VA, WA, WI, WV. International Distribution: AE, AU, CH, DE, FI, FR, GB, HK, IE, PA, PR, PT, RU, SG, and ZA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2999-2020
- Speed Stitch Needle Cassette
Terminated Class II Medical devices
- Recall started
- 21 February 2019
- Terminated
- 17 August 2022
- Reason
- The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
- Distribution
- US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, SC, SG, TN, TX, UT, VA, WA, WI, WV OUS: Austria, Belgium, Canada, Switzerland, Germany, Denmark, France, Englan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3000-2020
- Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
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.