Recall Z-3000-2020
ArthroCare Corporation · initiated February 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
Codes / lots: 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
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 taken
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.
Details
- Recall number
- Z-3000-2020
- Initiated
- February 21, 2019
- Terminated
- August 17, 2022
- Product code
- GAT – Suture, Nonabsorbable, Synthetic, Polyethylene
- Quantity
- 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)
- Recalling firm
- ArthroCare Corporation, Austin, TX