Howmedica recalls Tritanium TL Steerable Inserter (Cat. No. 48930000) due to locking mechanism failure that may cause implant misplacement during spinal surgery.
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.
Howmedica is recalling its Tritanium TL Steerable Inserter surgical device because the locking mechanism may not function properly, risking improper implant placement during spinal surgery. This could lead to the implant contacting sensitive anatomy or being placed in an incorrect position.
The locking mechanism may fail due to lack of lubrication, causing the implant to pivot unexpectedly during insertion. This could lead to the implant contacting sensitive anatomy or being placed in an incorrect position, potentially requiring additional surgery.
Surgeons and medical professionals who use this specific spinal implant device during procedures. Those with the product's serial number or model code are most at risk.
Check for the product model number 48930000 or unique device identifier 07613327381900 on the device packaging or label. This device is used in spinal surgery procedures.
Look for the model number 48930000 or unique device identifier 07613327381900 on the device packaging or label.
Howmedica received complaints that the locking mechanism on the steerable inserter may not function as intended due to lack of lubrication, which could cause the implant to pivot unexpectedly during surgery.
The device may cause the implant to contact sensitive anatomy or be placed in an incorrect position, potentially requiring additional surgery.
Check for the model number 48930000 or unique device identifier 07613327381900 on the device packaging or label.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0207-2019 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0207-2019 from Howmedica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
