distributed by Zimmer recall: Labeling Error
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El…
Why was distributed by Zimmer recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El…
- Recalling firm
- Synvasive Technology Inc
- Quantity
- 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.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)