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U.S. Department of Health and Human Services

Class 2 Device Recall INBONE Tibial Tray

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 Class 2 Device Recall INBONE Tibial Traysee related information
Date Initiated by FirmApril 09, 2020
Create DateMay 07, 2020
Recall Status1 Terminated 3 on November 02, 2020
Recall NumberZ-1924-2020
Recall Event ID 85439
510(K)NumberK051023 
Product Classification Prosthesis, ankle, semi-constrained, cemented, metal/polymer - Product Code HSN
ProductWRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Code Information Lot code 1619947
FEI Number 1043534
Recalling Firm/
Manufacturer		 Wright Medical Technology Inc
11576 Memphis Arlington Rd
Arlington TN 38002-9497
For Additional Information ContactMr. Kevin C. Smith
952-921-7121
Manufacturer Reason
for Recall		One lot of INBONE Tibial Trays is missing the plasma coating.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm initiated the recall by letter on 04/09/2020. The letter requested the consignee immediately cease use and quarantine the product for return.
Quantity in Commerce22 units
DistributionUS Nationwide distribution.
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 = HSN
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