ArthroCare

5 recalls •

• Categories: Other Medical Devices, Surgical Instruments, Infusion Pumps

Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

Class I - Dangerous

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.

Feb 21, 2019 Other Medical Devices Nationwide View Details →

Speed Stitch Needle Cassette

Class I - Dangerous

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.

Aug 17, 2020 Surgical Instruments Nationwide View Details →

TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01

Class I - Dangerous

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.

Mar 3, 2016 Other Medical Devices Nationwide View Details →

Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in spinal procedures.

Class I - Dangerous

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.

Oct 26, 2015 Other Medical Devices Nationwide View Details →

EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.

Class I - Dangerous

Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications.

Jun 2, 2015 Infusion Pumps Nationwide View Details →