Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Reported: December 19, 2018 Initiated: November 28, 2018 #Z-0605-2019
Product Description
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
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.
Details
- Recalling Firm
- Howmedica Osteonics Corp.
- Units Affected
- 28,461
- Distribution
- US Nationwide
- Location
- Allendale, NJ
Frequently Asked Questions
What product 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.. Recalled by Howmedica Osteonics Corp.. Units affected: 28,461.
Why was this product recalled? ▼
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2018. Severity: Moderate. Recall number: Z-0605-2019.
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