TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Summary
The FDA issued a Class II for TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement C by Howmedica Osteonics Corp.. Reason: Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLO.
Details
Source
Device Recall
External ID
Z-1654-2023
Action Date
2023-06-07
Status
Ongoing
Category
device
Product Description
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Lot/Code Info: GTIN: 07613327338560 Lot Number: 7H8RPL
Quantity Affected: 24 units in total
Reason for Recall
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
Distribution
US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-13
Company
Mahwah, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Howmedica Osteonics Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Howmedica Osteonics Corp. have FDA actions?
Howmedica Osteonics Corp. has 113 FDA actions in our database, including 113 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1654-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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