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Recall Observatory FDA recall evidence

Device product

Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants

Z-2418-2016

November 25, 2015

Class II

Product summary

Firm
Biomet 3i, LLC
Event
Event 73184
Status
Terminated
Classification
Class II
Quantity
1,648,273 (all products subject to these recall)
Official record key
device-enforcement:Z-2418-2016

Official wording

Reason: Pouches may not have been sealed during packing.

Code information: Lot # 1157768-CN, 1160929-CN, 1160930-CN, 1160931-CN, 987129-5, 996343-5, and 998147-5

Distribution pattern: Worldwide Distribution Nationwide andHawaii, Guam, Puerto Rico and Virgin Islands (U.S.) . FOREIGN CONSIGNEES: Albania, Andorra, Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Denmark, Dominican Republic, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Korea (South), Kuwait, Lebanon, Liechtenstein, Lithuania, Martinique, Mexico, Mongolia, Netherlands, Northern Mariana Islands, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tabago, Turkey, United Arab Emirates, Uruguay and Viet Nam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Pouches may not have been sealed during packing.