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Class 2 Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws |
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Date Initiated by Firm |
May 10, 2016 |
Create Date |
June 14, 2016 |
Recall Status1 |
Terminated 3 on December 16, 2016 |
Recall Number |
Z-1965-2016 |
Recall Event ID |
74114 |
Product Classification |
Plate, fixation, bone - Product Code HRS
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Product |
TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws
The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System. |
Code Information |
Lot UP15H2, Lot UP09D3, Lot UP07E2 |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. 311 Enterprise Dr Plainsboro NJ 08536-3344
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For Additional Information Contact |
Customer Service 609-275-0500
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Manufacturer Reason for Recall |
As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. The number should be 4, it is 6.
3) The space / holder
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FDA Determined Cause 2 |
Process design |
Action |
The firm, Integra Lifesciences, sent an "Urgent: Voluntary Medical Device Recall" letter dated 5/10/16 to affected consignees/customers via traceable courier service on 5/10/16. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using and distributing product immediately; complete and return the Recall Acknowledgement and Return Form via fax to 1-609-275-9445 or email to FCA2@integralife.com, even if you do not have any of the product.
Should you have any questions, please contact Customer Service at 1-866-854-8300. |
Quantity in Commerce |
71 units |
Distribution |
US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA. |
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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