Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjun
Summary
The FDA issued a Class II for Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace by Biomet, Inc.. Reason: Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch.
Details
Source
Device Recall
External ID
Z-1018-2023
Action Date
2023-02-01
Status
Ongoing
Category
device
Product Description
Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Lot/Code Info: UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830
Quantity Affected: 7 units
Reason for Recall
Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Distribution
Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-15
Company
Warsaw, IN
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 403 device-related FDA actions this month.
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 clearances.
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 (Biomet, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomet, Inc. have FDA actions?
Biomet, Inc. has 66 FDA actions in our database, including 60 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1018-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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