Ascent Healthcare Solutions ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 195182***Expiration Date: 11/2011. ***CAT 375-951-112***STRYKER***Arthroscopic Burr***5.0mm BARREL BUR***Hollow 12 Flute***BLUE***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 194245***Expiration Date: 11/2011. Reprocessed arthr Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.