Stryker 4.0 mm. Angled Aggressive 12 Degree Blade, Precision Cutters, Stryker Instruments, Kalamazoo, MI 49001 USA, (269

FDA device recall Z-2794-2011 · posted 2011-07-12 · Terminated

Recall details

Recalling firm

Stryker Instruments Division of Stryker Corporation

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.

Action taken

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

Status

Terminated

Product code

GFA

Quantity affected

95 Units

Distribution

Worldwide Distribution - USA including CA, LA,, MI, NJ, OH, OR, AR, IN, and Internationallly to Australia, Duisburg, Newbury and Hong Kong.

Date initiated

2011-06-13

Date posted

2011-07-12

Date terminated

2011-08-03

Location

Kalamazoo, MI