Howmedica Recalls 130 AccuLIF TL Insertion Handles Due to Pivot Defect
Howmedica Osteonics Corp. is recalling 130 AccuLIF TL Insertion Handles because the implant may pivot instead of maintaining a rigid connection when the lever is locked.
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 is classified as FDA Class II. The hazard involves a mechanical failure in a surgical instrument that could lead to improper implant placement, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling 130 units of the AccuLIF TL Insertion Handle, distributed nationally. The device is a surgical instrument designed to attach to an implant to allow a surgeon to insert it into the disc space for intervertebral body fusion in patients with degenerative disc disease.
The recall is due to a defect where the implant may be able to pivot rather than maintaining a rigid connection when the lever of the Insertion Handle is in the "locked" position. This failure to maintain a fixed engagement could compromise the controlled positioning of the implant during surgery.
The affected units are identified by Model # 800804 and Lot numbers 160010 and 170003. Healthcare facilities and distributors should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 130
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)
- Model# 800804 Lot numbers 160010 and 170003
Distribution
Distribution scope not specified by the agency.
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