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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Event Detail

Event ID 64810
Product Type Devices
Status Ongoing
Recalling Firm Synvasive Technology Inc
City El Dorado Hills
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-02
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide) and countries of: Austria, Australia, Belgium, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, Panama, Spain, Sweden, Switzerland, Tunisia, United Kingdom and Yemen.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement. Lots Numbers included in Recall: 1X311,01251,16325,15023,15024,1Y224,23326,0X401,26385,1Y174, 17151,0Y280,17150,22028,28114,19071,23372,23346,23504,23505, 25134,25341,2W223,2X105,26001,2W573,2W574,24348,25304, 25333,26068,26165,27015,27016,29392,PD4647 Class II Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System. 3442 units per the part numbers listed Z-1115-2013
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