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Class 2 Device Recall Triathlon Tritanium Tibial Component (Baseplate), Size 4 |
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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
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Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
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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
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For Additional Information Contact |
Loriann Russo 201-831-5272
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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.
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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
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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.
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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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