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U.S. Department of Health and Human Services

Class 2 Device Recall Tritanium Posterior Lumbar (PL) cage

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 Class 2 Device Recall Tritanium Posterior Lumbar (PL) cagesee related information
Date Initiated by FirmNovember 28, 2018
Create DateDecember 13, 2018
Recall Status1 Terminated 3 on May 28, 2020
Recall NumberZ-0605-2019
Recall Event ID 81587
510(K)NumberK152304 
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
ProductTritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
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
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactTimothy Huntington
201-749-8346
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionUrgent Medical Device Correction letters were sent to customers on 11/28/18.
Quantity in Commerce28,461
DistributionUS Nationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MAX
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