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U.S. Department of Health and Human Services

Enforcement Report - Week of January 22, 2014

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Product Detail

Product Description Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Recall Number Z-0716-2014
Classification Class II
Code Info Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Product Distributed Qty 52
Reason For Recall 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.

Event Detail

Event Id 67142
Product Type Devices
Status Ongoing
Recalling Firm Biomet, Inc.
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-12-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.