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U.S. Department of Health and Human Services

Enforcement Report - Week of August 1, 2012
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Event Detail

Event ID 62307
Product Type Devices
Status Ongoing
Recalling Firm Synthes USA HQ, Inc.
City West Chester
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-22
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface). Lot #2724103 Expiration 4/29/2012 REF 04.019.038S Class II Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. 20 Z-2059-2012
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface). Lot #2721745 Expiration 4/29/2012 REF 04.019.028S Class II Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. 20 Z-2060-2012
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