| Class 2 Device Recall Provide Protection Cap | |
Date Initiated by Firm | November 25, 2015 |
Date Posted | August 12, 2016 |
Recall Status1 |
Terminated 3 on July 26, 2019 |
Recall Number | Z-2441-2016 |
Recall Event ID |
73184 |
510(K)Number | K934126 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product | Provide Protection Cap
Dental implants |
Code Information |
Item: PPC484, PPC485, PPC654 and PPC655. |
Recalling Firm/ Manufacturer |
Biomet 3i, LLC 4555 Riverside Dr Palm Beach Gardens FL 33410-4200
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For Additional Information Contact | Mark Mashburn 561-776-6700 |
Manufacturer Reason for Recall | Pouches may not have been sealed during packing. |
FDA Determined Cause 2 | Packaging |
Action | Biomet sent an Urgent Device Recall Notice to all affected consignees the week of November 30, 2015, communicating the issue and customer responsibilities. International consignees were notified via traceable courier or email week of November 30, 2015. Customers were instructed to return affected product by calling BIOMET at 1-800-342-5454 to obtain a RMA number to return products. Customers were also asked to complete the Business Reply Form and fax to 561-514-6316.
For questions regarding this recall call 561-776-6700. |
Quantity in Commerce | 1,648,273 devices (all products subject to this recall) |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DZE
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