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U.S. Department of Health and Human Services

Enforcement Report - Week of January 23, 2013

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Event Detail

Event ID 63863
Product Type Devices
Status Ongoing
Recalling Firm Stryker Howmedica Osteonics Corp.
City Mahwah
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution, including the states of PA, OH, NY, CA and IL.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003. Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996. Class II Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients. 476 units Z-0695-2013