Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall STRYKER 4.0 mm ANGLED AGGRESSIVE 12 DEGREE BLADE see related information
Date Initiated by Firm June 13, 2011
Date Posted July 12, 2011
Recall Status1 Terminated 3 on August 03, 2011
Recall Number Z-2794-2011
Recall Event ID 59057
Product Classification Blade, saw, general, &, plastic surgery, surgical - Product Code GFA
Product Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269) 323-7700 (800) 253-3210, Sterile, Single Use, Rx ONLY

For Functional Endoscopic Sinus Surgery for the incision of soft and osseous tissue in the sinus cavities, open plastic, and reconstructive surgery of the head and neck.
Code Information Lot number 10265CG2, Part number 5290-744-100
Recalling Firm/
Manufacturer		 Stryker Instruments Division of Stryker Corporation
4100 East Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact K.Kelly Smith
269-389-3584
Manufacturer Reason
for Recall		 Recalled device was packaged with the incorrect angled blade. The labeling indicates a 12 degree angle but the product has a 40 degree angle.
FDA Determined
Cause 2		 Labeling mix-ups
Action Stryker Instruments Division of Stryker CorporationOn 6/13/11 sent an 'URGENT MEDICAL DEVICE RECALL NOTIIFICATION" letter to all affected customers that included the device name, lot number, dates of distribution, reason for the recall, risks associated with use of the device, a photo of the device, instructions to quarantine and return the devices, and a form to fax back to the firm to confirm receipt and adherence to the recall letter.
Quantity in Commerce 95 Units
Distribution Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-