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U.S. Department of Health and Human Services

Class 2 Device Recall Triathlon Tritanium Tibial Component (Baseplate), Size 4

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  Class 2 Device Recall Triathlon Tritanium Tibial Component (Baseplate), Size 4 see related information
Date Initiated by Firm February 10, 2021
Create Date March 08, 2021
Recall Status1 Terminated 3 on May 30, 2023
Recall Number Z-1186-2021
Recall Event ID 87350
510(K)Number K123486  K141056  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
Code Information Catalogue # 5536-B-400, Lot Number CTD44301
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Loriann Russo
201-831-5272
Manufacturer Reason
for Recall		 Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
FDA Determined
Cause 2		 Under Investigation by firm
Action On 2/11/2021, Stryker issued Urgent Medical Device Recall notices to customers via UPS 2-day air stating Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized.
Quantity in Commerce 11 devices
Distribution Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = Stryker
510(K)s with Product Code = MBH and Original Applicant = STRYKER ORTHOPAEDICS
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