Home / Recalls / Howmedica Osteonics Corp. / Z-0605-2019

Z-0605-2019 Class II Terminated

Recalled by Howmedica Osteonics Corp. — Allendale, NJ

FDA device recall Z-0605-2019 was initiated by Howmedica Osteonics Corp. on Nov 28, 2018 and is designated Class II. 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. The recall status is terminated (terminated May 28, 2020). Affected quantity: 28,461.

Recall Details

Product Type
Devices
Report Date
Dec 19, 2018
Initiation Date
Nov 28, 2018
Termination Date
May 28, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28,461

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.

Distribution Pattern

US Nationwide

Code Information

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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0605-2019
openFDA file date
Oct 21, 2026
Loaded by RegDataLab
Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources