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U.S. Department of Health and Human Services

Class 2 Device Recall Synvasive

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 Class 2 Recall
Synvasive
see related information
Date Posted April 15, 2013
Recall Status1 Open
Recall Number Z-1115-2013
Recall Event ID 64810
Product Classification Blade, Saw, General & Plastic Surgery, Surgical - Product Code GFA
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
Synvasive Technology Inc
4925 Robert J Mathews Pkwy
El Dorado Hills, California 95762-5701
For Additional Information Contact Do¿a M. Reust,
916-939-3913
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Zimmer sent a Urgent Device Removal letter dated April 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers that received affected product from both Synvasive and from Zimmer Surgical will receive two customer letters, as each letter sets out specific item and lot numbers dependent upon distribution entity. Zimmer Distributors will also receive an e-mail notification. All notifications include a response form for both Synvasive and Zimmer distributors as well as customer consignees to account for product disposition (disposal in the field per facilities' sharps protocol). (1) Notifications will be mailed via Fed Ex to Risk Managers and Zimmer Distributors with inventory. (2) Notifications will be emailed to international geographies. (3) Notifications will be emailed all Zimmer Distributors. (4) A second Fed Ex mailing will be sent to domestic non-responding consignees. (5) Effectiveness phone calls will be made to any remaining domestic non-responding consignees. (6) If a customer reports they have further distributed the product, the secondary consignee identified will receive a notification from Zimmer. The scope of the recall is limited to certain confirmed lots which were shipped to the affected consignees. .E-mails, certified mail receipts, and telephone records will be the firm's course of action in monitoring effectiveness checks. All returns will be stored in a separate area away from regular inventory. Final disposition of returned product is yet to be determined. The firm's recall strategy appears to be adequate. For further questions please call (916) 939-3913.
Quantity in Commerce 3442 units per the part numbers listed
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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