Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation
Summary
The FDA issued a Class II for Exactech Connexion GXL acetabular polyethylene liners used in the following syst by Exactech, Inc.. Reason: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical impla.
Details
Source
Device Recall
External ID
Z-2130-2021
Action Date
2021-07-28
Status
Ongoing
Category
device
Product Description
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm ID. Orthopedic hip implant component.
Lot/Code Info: All serial numbers. UDI-DI number: 10885862024503
Quantity Affected: 89,050 total
Reason for Recall
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
Distribution
Distribution US nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-29
Company
Gainesville, FL
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 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 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 (Exactech, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Exactech, Inc. have FDA actions?
Exactech, Inc. has 110 FDA actions in our database, including 97 recalls and 13 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2130-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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