FDAClass IIDecember 24, 2014

PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N recall

PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating…

Why was PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N recalled?

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

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?

640479 746680 845051 845054 845853 846770 847447 09J0185 1047072 1141611 1142909 1144321 1144617 1145797 1145932 1147072 1147100 1246368 1341559 1343124 1344997

Product
PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating…
Recalling firm
Stryker Endoscopy
Quantity
180,573 units
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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