ArthroCare Recalls
5 recalls on record · July 29, 2015 to September 30, 2020 · Medical Devices
Recalls by year
15
16
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 30, 2020Medical DevicesFDA
ArthroCare Corporation recalls Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Hazard: 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.
September 30, 2020Medical DevicesFDA
ArthroCare Corporation recalls Speed Stitch Needle Cassette
Hazard: 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.
April 13, 2016Medical DevicesFDA
ArthroCare Corporation recalls TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF
Hazard: During functional testing of devices after real time aging, it was determined that product failed to meet shelf-life at the expiration date indicated on the product labels.
January 20, 2016Medical DevicesFDA
ArthroCare Corporation recalls Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood ves
Hazard: There is cracking in the tray when the device is snapped into place. The crack is through the full thickness of the tray, compromising the sterile barrier.
July 29, 2015Medical DevicesFDA
ArthroCare Corporation recalls EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are
Hazard: Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.