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U.S. Department of Health and Human Services

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 Class 2 Recall
MAYFIELD® Composite Series Base Unit Standard		see related information
Date Posted February 21, 2013
Recall Number Z-0869-2013
Product MAYFIELD® Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD® Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
Code Information Model # A3101 Base Units Serial No's: SB120016, SB120017, SB120019, SB120020, SB120021, SB120022, SB120023, SB120024, SB120025, SB120026, SB120027, SB120028, SB120029, SB120030, SB120031, SB120032, SB120134, SB120036, SB120037, SB120038, SB120040, SB120042, SB120043, SB120044, SB120045, SB120049, SB120050, SB120051, SB120052, SB120053, SB120054, SB120055, SB120056, SB120057, SB120058, SB120059, SB120060, SB120061, SB120062, SB120063, SB120064, SB120065, SB120066, SB120067, SB120068, SB120069, SB120070, SB120071, SB120072, SB120073, SB120074, SB120075, SB120076, SB120077, SB120078, SB120079, SB120080, SB120081, SB120082, SB120083, SB120084, SB120085, SB120086, SB120087, SB120088, SB120089, SB120090, SB120091, SB120092, SB120093, SB120094, SB120095, SB120096, SB120097, SB120098, SB120099, SB120100, SB120107, SB120108, SB120109, SB120111, SB120112, SB120113, SB120114, SB120115, SB120116, SB120117, SB120118, SB120119, SB120120, SB120121, SB120122, SB120129, SB120131, SB120138 & SB120141.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro, New Jersey 08536-3344
For Additional Information Contact Michael Molloy
513-533-7944
Reason for
Recall		 Integra determined there is a possibility that the Base Units may break during use.
Action Integra LifeSciences Corporation sent an Urgent Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product immediately and also remove them from service to prevent any further use of the affected product. Integra would provide an alternative base unit to replace those customers could no longer use. Customers were asked to complete the Recall Acknowledgement and Return Form to ensure they received this information. For assistance customers were instructed to call 1-513-533-7944 or 1-513-533-7946.
Quantity in Commerce 96 units
Distribution Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium.
 
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