Summary
The FDA issued a Class II for Identity Imprint PS Tibial Tray Size 4: Lot 540287 by Conformis, Inc.. Reason: Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between .
Details
Source
Device Recall
External ID
Z-1591-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Lot/Code Info: Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287
Quantity Affected: 3 units
Reason for Recall
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Distribution
US Nationwide distribution in the states of FL, KS and NH.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-11
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 179 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-1591-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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