Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
FDA Recall Z-0605-2019 · Posted None
Recalling FirmHowmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMAX
Date Initiated2018-11-28
Date Terminated2020-05-28
Product Quantity28,461
Reason for Recall
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Firm Action
Urgent Medical Device Correction letters were sent to customers on 11/28/18.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.