iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Summary
The FDA issued a Class II for iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: by Conformis, Inc.. Reason: Incorrect tibial base plate implant packaged in kit.
Details
Source
Device Recall
External ID
Z-0899-2022
Action Date
2022-04-20
Status
Completed
Category
device
Product Description
iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
Lot/Code Info: Serial Number: 0496242 UDI: M572TPS3011113011
Quantity Affected: 1 unit
Reason for Recall
Incorrect tibial base plate implant packaged in kit
Distribution
MS
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-22
Company
Billerica, MA
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.
Conformis, Inc. has 16 FDA actions in our database, including 5 recalls and 11 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 (Conformis, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Conformis, Inc. have FDA actions?
Conformis, Inc. has 16 FDA actions in our database, including 5 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0899-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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