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U.S. Department of Health and Human Services

Class 2 Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws

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 Class 2 Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screwssee related information
Date Initiated by FirmMay 10, 2016
Create DateJune 14, 2016
Recall Status1 Terminated 3 on December 16, 2016
Recall NumberZ-1965-2016
Recall Event ID 74114
Product Classification Plate, fixation, bone - Product Code HRS
ProductTS 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
FEI Number 3003418325
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information ContactCustomer Service
609-275-0500
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
FDA Determined
Cause 2		Process design
ActionThe 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 Commerce71 units
DistributionUS Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
Total Product Life CycleTPLC Device Report
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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