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CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm… recallZ-0957-2012 · Ascent Healthcare Solutions · initiated Jan 26, 2009

Terminated All recalls posted in February 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Ascent Healthcare Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-0957-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 26, 2009
Posted by the FDA
Feb 3, 2012
Recalling firm
Ascent Healthcare Solutions
Quantity
1575 devices
Product code
HRX
FDA submissions
K012605, K012635
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.

Product description

***CAT 375-544-000***STRYKER***Arthroscopic Blade***4.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 200860***Expiration Date: 01/2012. ***CAT 375-554-000***STRYKER***Arthroscopic Blade***5.0mm AGGRESSIVE PLUS***Hub Style - Formula***Red/Lt Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 200860***Expiration Date: 01/2012. 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.

Code information (models, lots, serial numbers)

Lot numbers: 200860 and 194240.

Other devices under the same FDA submission

7 devices cleared under K012605, K012635 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 58937).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page