Recall Z-3000-2020 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
ArthroCare Corporation
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
| Date | Feb 21, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root 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 |
| 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, Pola |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123268 | SMARTSTITCH PERFECTPASSER SYSTEM Arthocare Corporation, Nov 7, 2012 |