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U.S. Department of Health and Human Services

Class 2 Device Recall SYNTHES 2.0MM DRILL BIT STRYKER JLATCH/60MM

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  Class 2 Device Recall SYNTHES 2.0MM DRILL BIT STRYKER JLATCH/60MM see related information
Date Initiated by Firm September 03, 2009
Date Posted October 26, 2009
Recall Status1 Terminated 3 on March 08, 2010
Recall Number Z-0082-2010
Recall Event ID 53327
Product Classification Surgical Orthopedic Instrument Ac-Powered Motor and Accessory/Attachment - Product Code HWE
Product SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853.

Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery.
Code Information Lot # N64648, 6082633, and 6107223.
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Ed Hung
610-719-5865
Manufacturer Reason
for Recall		 The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification.
FDA Determined
Cause 2		 PMA
Action The customer account was notified by an Urgent: Medical Device Removal letter via USPS certified mail on 9/4/2009. The letter stated that the products did not have clearance for the hospital's intended use and that if the customer has any of the identified devices, they should call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Also, the customer should complete the Verification Section, and return the letter along with any remaining product. For questions the hospital could call 610-719-5865.
Quantity in Commerce 57
Distribution Nationwide Distribution -- State of CA.
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.
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