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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Synthes Multi-Vector Distractor Body, Part Number 487.931		see related information
Date Posted March 01, 2013
Recall Number Z-0903-2013
Product Synthes Multi-Vector Distractor Body, Part Number 487.931. For mandibular bone lengthening.
Code Information Part number 487.831 - Lot numbers 7826459,7750064, 7667285, and 7806090.
Recalling Firm/
Manufacturer		 Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Action The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice.
Quantity in Commerce 2
Distribution Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT.
 
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