Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Summary
The FDA issued a Class II for Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis by Stryker Leibinger GmbH & Co. KG. Reason: Device was shipped without having regulatory approval..
Details
Source
Device Recall
External ID
Z-1234-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product Description
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Lot/Code Info: TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Quantity Affected: 1 unit
Reason for Recall
Device was shipped without having regulatory approval.
Distribution
Distribution of one unit only to a single customer in MA (USA)
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-06
Company
Freiburg Im Breisgau
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.
Stryker Leibinger GmbH & Co. KG has 18 FDA actions in our database, including 4 recalls and 14 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 (Stryker Leibinger GmbH & Co. KG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Leibinger GmbH & Co. KG have FDA actions?
Stryker Leibinger GmbH & Co. KG has 18 FDA actions in our database, including 4 recalls and 14 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1234-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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