Summary
The FDA issued a Class II for Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700 by Howmedica Osteonics Corp.. Reason: The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal pro.
Details
Source
Device Recall
External ID
Z-2329-2021
Action Date
2021-08-25
Status
Terminated
Category
device
Product Description
Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
Lot/Code Info: Lot JHS2H
Quantity Affected: 14 US; 2 OUS
Reason for Recall
The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.
Distribution
Worldwide distribution - US Nationwide distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-01
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 221 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-2329-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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