TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization
Summary
The FDA issued a Class II for TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended f by Synthes (USA) Products LLC. Reason: TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in le.
Details
Source
Device Recall
External ID
Z-1248-2023
Action Date
2023-03-22
Status
Ongoing
Category
device
Product Description
TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
Lot/Code Info: UDI-DI: 10886982097262 Lot Number: 610P788
Quantity Affected: 6 units
Reason for Recall
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
Distribution
Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-01
Company
West Chester, PA
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 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Synthes (USA) Products LLC has 26 FDA actions in our database, including 24 recalls and 2 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 (Synthes (USA) Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Synthes (USA) Products LLC have FDA actions?
Synthes (USA) Products LLC has 26 FDA actions in our database, including 24 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1248-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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