FDAClass IIDecember 24, 2014

PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS recall

PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 20CM, P/N 0250282000 Laparoscopic Manual Instruments are intended for cutting, holding, grasping…

Why was PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS 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?

342970 645484 743722 747490 747891 840091 945208 945712 946001 1040121 1041472 1042482 1042952 1046585 1140928 1143074 1143076 1143121 1145963 1146536 1241511 1244708 1246167 1341512 1343689 1344271 1344682 1440414

Product
PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 20CM, P/N 0250282000 Laparoscopic Manual Instruments are intended for cutting, holding, grasping…
Recalling firm
Stryker Endoscopy
Quantity
180,573 units total
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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