Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument...
FDA Recall #Z-0634-2022 — Class II — December 22, 2021
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
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.
Recalling Firm
Synthes (USA) Products LLC — West Chester, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
600 units
Distribution
US Nationwide distribution.
Code Information
Lot/Serial No.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201 21869701, 21983904, 21995301 GTIN: 10886982297372
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated