Recall Z-0947-2012 ยท HRX Arthroscope
Ascent Healthcare Solutions
***CAT 7205305***DYONICS***Arthroscopic Blade***3.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Beige***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 199468***Expiration Date: 12/2011. ***CAT 7205306***DYONICS***Arthroscopic Blade***4.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Yellow***SAMPLE LATEX-FRE
| Date | Feb 3, 2012 (initiated Jan 26, 2009) |
| Status | Terminated |
| Reason | On 01/26/2009, Ascent Healthcare Solutions, Lakeland, FL initiated a recall of various models of Dyonics, Stryker, and Linvatech Reprocessed Arthroscopic Shaver Blades. The sterility of the devices may be compromised due to a potential breach in the seal of the Tyvek cover to the plastic tray. |
| Root cause | Packaging process control |
| Action | Ascent Healthcare Solutions sent an "URGENT MEDICAL DEVICE VOLUNTARY RECALL" letter dated January 26, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to examine their inventory, remove and quarantine all affected devices. A Recall Effectiveness Check Form was attached for customers to complete and return via fax to 1-866-325-4760. Contact the firm at (888) 888-3433 ext. 5519 for questions regarding this recall. |
| Quantity | 330 devices |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI, and WY, and the country of Canada. |
| FDA record | Open on fda.gov |