FDA-Device2018-12-19Class II
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Howmedica Osteonics Corp.
Hazard
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Sold states
US Nationwide
Affected count
28,461
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0605-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief