Recall Z-0207-2019 ยท LXH Orthopedic Manual Surgical Instrument
Howmedica Osteonics Corp.
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. T
| Date | Sep 12, 2018 |
| Status | Terminated |
| Reason | 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 positioni |
| Root cause | 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 | 58 |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.