Summary
The FDA issued a Class II for 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122 by Howmedica Osteonics Corp.. Reason: There is a potential for the outer white Tyvek lid to debond from the sealed package..
Details
Source
Device Recall
External ID
Z-0314-2022
Action Date
2021-12-08
Status
Ongoing
Category
device
Product Description
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Lot/Code Info: UDI number - (01) 07613327013016(17)261013(10); lot numbers - 86604305, 86604306
Reason for Recall
There is a potential for the outer white Tyvek lid to debond from the sealed package.
Distribution
Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-15
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 131 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-0314-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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