| Class 2 Device Recall Straumann Bone Level Implant | |
Date Initiated by Firm | July 14, 2016 |
Create Date | August 12, 2016 |
Recall Status1 |
Terminated 3 on November 20, 2020 |
Recall Number | Z-2534-2016 |
Recall Event ID |
74799 |
510(K)Number | K150938 |
Product Classification |
Implant, endosseous, root-form - Product Code DZE
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Product | Straumann Bone Level Implant, 4.1mm RC, SLA 10mm, TiZr, NTP
Article Number: 021.4510 |
Code Information |
Lot Numbers: LR810; LT122 |
Recalling Firm/ Manufacturer |
Straumann Manufacturing, Inc. 60 Minuteman Rd Andover MA 01810-1008
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For Additional Information Contact | SAME 800-448-8168 |
Manufacturer Reason for Recall | Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Straumann notified customers via telephone on Thursday, July 14, 2016. Customers with an e-mail address on file
were also e-mailed on Friday, July 15, 2016.Straumann notified customers were sent a hard copy letter via UPS on Saturday, July 16, 2016 for delivery on Monday, July 18, 2016.
The customers have been notified not to use these implants and to return unused implants to Straumann. The customers that have used the implants have been asked to provide the restorative situation for the implants. Depending on the restorative situation, additional instructions may be necessary to restore the implants. |
Quantity in Commerce | 70 pieces |
Distribution | Nationwide Distribution. |
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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