FDA Device recall Z-0605-2019
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant by Howmedica Osteonics, citing the surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0605-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-28 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Howmedica Osteonics |
| Distribution | US |
Product
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Reason
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Identifiers
| code_info | UDI: 07613327117943, All lots, Model Numbers 48950070, 48950076, 48950080, 48950086, 48950090,48950096, 48950100, 48950…UDI: 07613327117943, All lots, Model Numbers 48950070, 48950076, 48950080, 48950086, 48950090,48950096, 48950100, 48950106, 48950110, 48950116,48950120, 48950126, 48950130, 48950136, 48950140, 48950146, 48951070, 48951076, 48951080, 48951086, 48951090,48951096, 48951100, 48951106, 48951110, 48951116, 48951120, 48951126,48951130, 48951136,48951140, 48951146, 48952070, 48952080, 48952090, 48952100, 48952110, 48952120, 48952130,48952140,48953070, 48953080, 48953090, 48953100, 48953110, 48953120, 48953130, 48953140, 48954076,48954086, 48954096,48954106,48954116, 48954126, 48954136, 48954146, 48955076, 48955086, 48955096, 48955106, 48955116, 48955126, 48955136, 48955146, Vl/48950090, Vl/48953090, Vl/48955096, 48950066, 48954066, 48951092, 48951112, 48951132, 48950092, 48950112, 48950132,48956086,48956096,48956106, 48956116, 48956126,48956136, 48956146,48956140,48957092,48957112, 48957132, 48956112, 48956132, 48952092,48952112, 48952132, 48953092, 48953112, 48953132, 48950102, 4895 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Howmedica Osteonics recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0605-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.