Recall Z-1927-2011 ยท HRX Arthroscope
Stryker Endoscopy
Inflow/Outflow Cannula; Qty: 1; distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138 The inflow/outflow cannula is intended as a general purpose, concomitant suction and irrigation device for use in endoscopic surgeries. It will be used by orthopedic surgeons in arthroscopic knee and shoulder procedures as well as used in conjunction with the Stryker Flow Control Arthroscopy p
| Date | Apr 8, 2011 (initiated Mar 7, 2011) |
| Status | Terminated |
| Reason | Insufficient cleaning instruction were included for the Inflow/outflow Cannula in the user manual. |
| Root cause | Other |
| Action | The firm, Stryker, issued an "URGENT: DEVICE CORRECTION" memo dated March 8, 2011 to all customers. The memo described the product, problem and actions to be taken. The customers were instructed to discard any old Instructions for Use (1000-400-816 rev. A or B) for their Inflow/Outflow Cannual; download the new IFU (1000-400-816 rev. C) from the URL link: http://stryker.com/InflowOutflowCannual; ensure they follow the new cleaning instructions provided in the IFU and complete and return the enclosed "acknowledgement of receipt" form and fax to (408) 754-8378 or scan in and email to cannula@str |
| Quantity | 2618 devices |
| Distribution | Worldwide distribution: USA including states of: AL, ALASKA, AK, AR, CA, CO, CT, DC, DE, FL, GA, ID IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of: Australia, Canada, China, France, Germ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944210 | ARTHROSCOPE ACCESSORIES Stryker Endoscopy, Feb 14, 1995 |