Howmedica Recalls Tritanium TL Steerable Inserter Due to Locking Mechanism Failure
Howmedica Osteonics Corp. is recalling 58 units of the Tritanium TL Steerable Inserter because the locking mechanism may fail to function as intended due to lack of lubrication.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of harm (contact with sensitive anatomy or suboptimal implant placement) during surgery, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 58 units of the Tritanium TL Steerable Inserter, Catalog No. 48930000, UDI 07613327381900. The product is a Class 1 surgical instrument provided in a non-sterile condition, designed to enter the disc space and rotate for desired placement of an implant. The recall covers all lots of the product, which was distributed nationwide in the United States.
The recall was initiated after the firm received complaints that the locking mechanism on the steerable inserter was not functioning as intended. The firm confirmed that the issue is related to a lack of lubrication of the instrument. This malfunction creates potential hazards during surgical procedures, including the implant pivoting unexpectedly, which could cause it to unintentionally contact sensitive anatomy. Additionally, the lack of rigidity may make it difficult to position the implant, and the inserter may fail to unlock at the articulating pivot head, potentially resulting in the implant being placed in a suboptimal trajectory.
The recalled product
- 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…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 58
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
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