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Terminated

***CAT 7205310***DYONICS***Arthroscopic Blade***4.5mm SYNOVATOR, 13cm long***Fits Power/EP-1 Motor Drives***Forest Green***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197854***Expiration Date: 12/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

FDA Recall Z-0948-2012 · Posted 2012-02-03

Recalling FirmAscent Healthcare Solutions
Recall StatusTerminated
Product CodeHRX
Date Initiated2009-01-26
Date Terminated2012-03-09
Product Quantity18 devices

Reason for Recall

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.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012652REPROCESSED DYONICS ARTHROSCOPIC BURSAlliance Medical Corp. · 2001-11-08K012611REPROCESSED DYONICS ARTHROSCOPIC SHAVERSAlliance Medical, Inc. · 2001-11-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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