Summary
The FDA issued a Class II for Integra Universal Flexible Arm part number REF 1362275 by Integra LifeSciences Corp.. Reason: Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition..
Details
Source
Device Recall
External ID
Z-0906-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
Integra Universal Flexible Arm part number REF 1362275
Lot/Code Info: UDI#10381780074670, Lots: AC2109, AC2103, AC2106, AC2110, AC2101, AC2008, AC2009
Quantity Affected: 54
Reason for Recall
Excess force used to tighten the Universal Flexible Arm can cause the internal cable to break at the tip, resulting in an unusable condition.
Distribution
US Nationwide Distribution: AL, AZ, FL, GA, IL, MA, MD, NY, OH, OR, PA, TX
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-28
Company
Princeton, 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 403 device-related FDA actions this month.
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 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 (Integra LifeSciences Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. have FDA actions?
Integra LifeSciences Corp. has 64 FDA actions in our database, including 64 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0906-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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