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.
FDA Recall Z-2794-2011 · Posted 2011-07-12
Recalling FirmStryker Instruments Division of Stryker Corporation
Recall StatusTerminated
Product CodeGFA
Date Initiated2011-06-13
Date Terminated2011-08-03
Product Quantity95 Units
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.