Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for steriliz
Summary
The FDA issued a Class II for Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, a by Howmedica Osteonics Corp.. Reason: Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro .
Details
Source
Device Recall
External ID
Z-0459-2022
Action Date
2022-01-12
Status
Ongoing
Category
device
Product Description
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee arthroplasty (TKA). Catalog# 6541-9-109
Lot/Code Info: Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
Quantity Affected: 7 units
Reason for Recall
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
Distribution
US Nationwide distribution in the states of GA, MI, NC, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-11-24
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 114 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-0459-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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