Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in t
Summary
The FDA issued a Class II for Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alter by Synthes (USA) Products LLC. Reason: Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall.
Details
Source
Device Recall
External ID
Z-0634-2022
Action Date
2022-02-16
Status
Ongoing
Category
device
Product Description
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nailing System (TFNA), RFN-ADVANCED" Retrograde Femoral Nailing System (RFNA), FRN-ADVANCED" Femoral Recon Nailing System (FRNA), and Flexible Monobloc Reamers. Instrument Handles are intended for holding instruments for manipulation during orthopedic surgery. Product No.: 03.043.001
Lot/Code Info: Lot/Serial No.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201 21869701, 21983904, 21995301 GTIN: 10886982297372
Quantity Affected: 600 units
Reason for Recall
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-22
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 154 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-0634-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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