Recall Z-1680-2013 ยท HRX Arthroscope
Linvatec Corp. dba ConMed Linvatec
***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
| Date | Jul 10, 2013 (initiated May 30, 2013) |
| Status | Terminated |
| Reason | Conmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site. |
| Root cause | Equipment maintenance |
| Action | ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery or equivalent on 5/30/2013 to all domestic direct consignees. ConMed Linvatec is translating customer notifications letters into the necessary languages and will send International notification letters no later than 6/4/2013. |
| Quantity | 4,691 Units total of each |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954440 | APEX TUBING SET Linvatec Corp., Nov 2, 1995 |