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Z-3000-2020 Class II Terminated

Recalled by ArthroCare Corporation — Austin, TX

FDA device recall Z-3000-2020 was initiated by ArthroCare Corporation on February 21, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated August 17, 2022). Affected quantity: 15,559 units.

Recall Details

Product Type
Devices
Report Date
September 30, 2020
Initiation Date
February 21, 2019
Termination Date
August 17, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,559 units

Product Description

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

Reason for Recall

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 Pattern

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, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)

Code Information

Batch Numbers: 1154857, 1179855, 1184077, 1194208, 2005153, 1154858, 1179856, 1184078, 1194763, 2005154, 1156429, 1179857, 1184825, 2001517, 2005251, 1165209, 1179858, 1184826, 2001518, 2005252, 1166194, 1179859, 1184827, 2001519, 2005494, 1168946, 1181657, 1184828, 2002828, 2006014, 1170928, 1181658, 1184829, 2002829, 2006037, 1170929, 1182577, 1184830, 2002830, 2006038, 1170930, 1182578, 1184831, 2002831, 2006039, 1170931, 1182579, 1185959, 2002832, 2006040, 1174530, 1182580, 1187253, 2004741, 1174531, 1182581, 1187254, 2004933, 1175357, 1182621, 1187255, 2004934, 1175401, 1182622, 1192014, 2005147, 1178577, 1184074, 1192015, 2005149, 1178578, 1184075, 1192016, 2005150, 1179854, 1184076, 1192017, 2005152

Other recalls by ArthroCare Corporation

  • Z-2999-2020 Class II — Speed Stitch Needle Cassette (August 17, 2020)
  • Z-1321-2016 Class II — TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH (March 3, 2016)
  • Z-0623-2016 Class II — Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of (October 26, 2015)
  • Z-2105-2015 Class II — EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable (June 2, 2015)

FDA data resources