***CAT 7205310***DYONICS***Arthroscopic Blade***4.5mm SYNOVATOR, 13cm long***Fits Power/EP-1 Motor Drives***Forest Green
FDA device recall Z-0948-2012 · posted 2012-02-03 · Terminated
Recall details
- Recalling firm
- Ascent Healthcare Solutions
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 18 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,
- Date initiated
- 2009-01-26
- Date posted
- 2012-02-03
- Date terminated
- 2012-03-09
- Location
- Phoenix, AZ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| REPROCESSED DYONICS ARTHROSCOPIC BURS (K012652) | Alliance Medical Corp. | 2001-11-08 |
| REPROCESSED DYONICS ARTHROSCOPIC SHAVERS (K012611) | Alliance Medical, Inc. | 2001-11-07 |