RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Summary
The FDA issued a Class II for RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip h by Biomet, Inc.. Reason: 41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical interventi.
Details
Source
Device Recall
External ID
Z-2179-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product Description
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
Lot/Code Info: Lot Number / UDI Number (1) 66540443 (01)00880304001923(17)290408(10)66540443; (2) 66601057 (01)00880304001923(17)290405(10)66601057; (3) 66623486 (01)00880304001923(17)290327(10)66623486; (4) 66635486 (01)00880304001923(17)290327(10)66635486
Quantity Affected: 12 units
Reason for Recall
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, NJ, PA, TX, VA and the country of Chile.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-17
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 167 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-2179-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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