Enforcement Report - Week of August 1, 2012
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Product Detail
| Product Description | 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). |
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| Recall Number | Z-2059-2012 |
| Classification | Class II |
| Code Info | Lot #2724103 Expiration 4/29/2012 REF 04.019.038S |
| Product Distributed Qty | 20 |
| Reason For Recall | Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. |
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. |
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