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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long

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  Class 2 Device Recall Stryker 7.5mm x 7.9mm XX Coarse Diamond Drum, Super Long see related information
Date Initiated by Firm November 30, 2010
Date Posted February 14, 2011
Recall Status1 Terminated 3 on April 13, 2011
Recall Number Z-1232-2011
Recall Event ID 57505
510(K)Number K032303  
Product Classification drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product Stryker 5190 TPS Series Burs. Powered simple cranial drills, burrs, trephines, and their accessories.

These burs are intended for use during various surgical procedures to cut hard tissue or bone and soft tissue. More specifically these burs are used for shaping the bone (femur) during orthopedic surgeries.
Code Information Part Number 5190021775; Lot 9190017  
Recalling Firm/
Manufacturer		 Stryker Instruments Division of Stryker Corporation
4100 East Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact K. Kelly Smith
800-800-4236 Ext. 3584
Manufacturer Reason
for Recall		 Product was packaged with an incorrect packaging material and therefore has a potential to be non-sterile which, if contaminated, could lead to a patient infection.
FDA Determined
Cause 2		 Packaging
Action The firm, Stryker, sent a "MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 2, 2010 to all customers. The letter described the product, problem and the action to be taken by the customers. The customer were asked to complete and fax in the business reply form indicating they have received the notification and to indicate whether or not they have affected product on hand, and send back any affected product to Regulatory Affairs at Stryker Instruments. Stryker will then send a replacement product to the customer. Upon receipt of the completed business reply form, the customer will be contacted to arrange return of any affected product they have in their inventory. Once the affected product is received, a replacement 5190 TPS Series Bur will be sent to the customer. For questions regarding this recall, please contact Stryker Instruments at 1-800-800-4236 ext. 3584 or kathleen.kelly.smith@stryker.com.
Distribution Worldwide distribution: USA including states of: CA, FL, LA, MI, MT, NE, NH, OH, PA, SD, TN, TX, VT, and WA; and countries including: Sweden and Australia.
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.
510(K) Database 510(K)s with Product Code = HBE and Original Applicant = STRYKER INSTRUMENTS
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