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U.S. Department of Health and Human Services

Class 2 Device Recall TITAN

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 Class 2 Device Recall TITANsee related information
Date Initiated by FirmDecember 20, 2017
Date PostedApril 20, 2018
Recall Status1 Terminated 3 on February 24, 2020
Recall NumberZ-1463-2018
Recall Event ID 79597
Product Classification Template - Product Code HWT
ProductThe humeral stems trials are packaged in a kit for Titan Modular Shoulder System under the following labeling: Catalog Number Product Description TRL092002506 Humeral Stem Trial, 6mm TRL092002507 Humeral Stem Trial, 7mm TRL092002508 Humeral Stem Trial, 8mm TRL092002509 Humeral Stem Trial, 9mm TRL092002510 Humeral Stem Trial, 10mm TRL092002511 Humeral Stem Trial, 11mm TRL092002512 Humeral Stem Trial, 12mm TRL092002513 Humeral Stem Trial, 13mm TRL092002514 Humeral Stem Trial, 14mm TRL092002515 Humeral Stem Trial, 15mm TRL092002516 Humeral Stem Trial, 16mm
Code Information TRL092002506  Lot Numbers: 19419-1 15916-1 15457-1 201274-1 201893-1 2046177  TRL092002507 Lot Numbers: 19419-2 15916-2 15457-2 201274-2 201893-2 2046178  TRL092002508 Lot Numbers: 19419-3 15916-3 15457-3 201274-3 201893-3 2046179  TRL092002509 Lot Numbers: 19419-4 15916-4 15457-4 201274-4 201893-4 20461710  TRL092002510 Lot Numbers: 19419-5 15916-5 15457-5 201274-5 201893-5 20461711  TRL092002511 Lot Numbers: 19419-6 15916-6 15457-6 201274-6 201893-6 20461712  TRL092002512  Lot Numbers: 19419-7 15916-7 15457-7 201274-7 201893-7 20461713  TRL092002513 Lot Numbers: 19419-8 15916-8 15457-8 201274-8 201893-8 20461714  TRL092002514  Lot Numbers: 19419-9 15916-9 15457-9 201274-9 201893-9 20461715  TRL092002515 Lot Numbers: 19419-10 15916-10 15457-10 201274-10 201893-10 20461716  TRL092002516 Lot Numbers: 19419-11 15916-11 15457-11 201274-11 201893-11 20461717 
FEI Number 3003418325
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact
609-275-0500
Manufacturer Reason
for Recall		Incidents of stem trial breakage were reported to the firm suggesting that these fractures all occurred during insertion/impaction or extraction of the humeral stem trial whiling preparing the humeral canal and/or trialing. All cases resulted in a delay in surgery, with a variance of medical intervention required.
FDA Determined
Cause 2		Device Design
ActionFirm sent letters to consignees on December 20, 2017. Firm asked consignees to examine inventory and determine if consignee had affected product. Firm promised to send new stem trials along with a return shipping label. Firm asked to complete the Acknowledgment and Return Form and email or fax back to firm. For further questions, please call (609) 275-0500.
Quantity in Commerce1619 units
DistributionWorldwide Distribution - USA (nationwide) Distribution.
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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