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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description 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.
Recall Number Z-1115-2013
Classification Class II
Code Info 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
Product Distributed Qty 3442 units per the part numbers listed
Reason For Recall 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.

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.
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