Medical device recalls Moderate risk

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.

Get recall alerts

Free email alert whenever Howmedica Osteonics Corp. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Howmedica Osteonics Corp.