• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Tritanium Posterior Lumbar (PL) cage

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Tritanium Posterior Lumbar (PL) cage see related information
Date Initiated by Firm November 28, 2018
Create Date December 13, 2018
Recall Status1 Open3, Classified
Recall Number Z-0605-2019
Recall Event ID 81587
510(K)Number K152304  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Tritanium 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 Contact Timothy 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
Action Urgent Medical Device Correction letters were sent to customers on 11/28/18.
Quantity in Commerce 28,461
Distribution US Nationwide
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = Stryker
-
-