Class 2 Device Recall SmartStitch Perfect Passer Connector

• Date Initiated by Firm: February 21, 2019
• Create Date: September 22, 2020
• Recall Status: Terminated on August 17, 2022
• Recall Number: Z-3000-2020
• Recall Event ID: 85321
• 510(K)Number: K123268
• Product Classification: Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
• Product: Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
• 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
• Recalling Firm/ Manufacturer: ArthroCare Corporation; 7000 W William Cannon Dr Bldg 1; Austin TX 78735-8509
• For Additional Information Contact: Smith-Nephew; 512-391-3900
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: On February 21, 2019, the firm sent an "Urgent Medical Device Recall Notice" via Federal Express and E-Mail to all affected consignees. In addition to providing information on the recall product the firm asked consignees to take the following actions: 1. Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to FieldActions@smith-nephew.com or fax to 901-566-7975. Please Note  even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. 6. If you have any questions or concerns regarding this recall please contact FieldActions@smith-nephew.com.
• Quantity in Commerce: 15,559 units
• 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, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GAT