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U.S. Department of Health and Human Services

Class 2 Device Recall Tritanium TL Steerable Inserter

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  Class 2 Device Recall Tritanium TL Steerable Inserter see related information
Date Initiated by Firm September 12, 2018
Create Date October 23, 2018
Recall Status1 Terminated 3 on July 16, 2020
Recall Number Z-0207-2019
Recall Event ID 81096
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900

Product Usage:
The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
Code Information All lots
Recalling Firm/
Manufacturer
Howmedica Osteonics Corp.
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact
201-760-8000
Manufacturer Reason
for Recall
The firm received complaints related to the locking mechanism on the steerable inserter not functioning as intended. The firm confirmed that the issue is related to lack of lubrication of the instrument. There are two potential hazards associated with the implant pivoting unexpectedly during implant insertion into the disc space. First, if the implant is initially inserted into the disc space via the impaction method and the implant pivots unexpectedly, the implant potentially may unintentionally contact sensitive anatomy. Additionally, the user may potentially experience difficulty positioning the implant within the disc space due to the lack of rigidity. A third potential hazard is associated with the inserter not unlocking at the articulating pivot head during implant positioning within the disc space. Once the implant is in the prepared disc space and contacts the ventral annulus, the surgeon unlocks the articulating pivot head and positions the implant perpendicular to the spinous process. The surgeon may then elect to lock/unlock the articulating pivot head for desired final positioning of the implant. If the inserter does not unlock during these final implant positioning steps, the user may potentially implant the cage in a suboptimal trajectory/placement.
FDA Determined
Cause 2
Under Investigation by firm
Action On September 12, 2018, the firm notified its sales personnel of the recall via a Product Correction letter. The letter identified the affected product, problem and actions to be taken. Applicable Stryker personnel that are involved in the maintenance or preparation of the Tritanium TL Inserter have been identified to receive notification of this correction to assure that the instrument is lubricated adequately.
Quantity in Commerce 58
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC 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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