Z-0605-2019Class II

Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive...

Name: Z-0605-2019 Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive...
Creator: Howmedica Osteonics Corp.
Published: 2018-11-28
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2018-11-28 / Terminated

FDA source

Howmedica Osteonics Corp. began a recall of Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical... on 2018-11-28. FDA classified it as Class II and gives the reason as "The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0605-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-28
Posted: 2018-12-13
Terminated: 2020-05-28
Recalling firm: Howmedica Osteonics Corp
Product: Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Correction letters were sent to customers on 11/28/18.
Quantity in commerce: 28,461
Distribution: US Nationwide
Product codes and lots: 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, 48950122, 48950142, 48951102, 48951122, 48951142, 48956076,48956092, 48956102, 48956122, 48956142, 48953102, 48953122, 48953142

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0605-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0605-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-13

Product code MAX

K152304Class IITritanium PL CageStryker / cleared 2015-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)