Howmedica Osteonics Corp. recalls Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minim…
- Recall date
- November 28, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0605-2019
- FDA classification
- Class II
- Brand / firm
- Howmedica Osteonics Corp.
- Sold / distributed
- US Nationwide
Why it was recalled
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
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