FDAFDA · Food and drugs·Recall number Z-0634-2022
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
Published February 16, 2022 · Recall initiated: December 22, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- US Nationwide distribution.
- Lot
- Lot/Serial No.: 20013101, 20052701, 20228901, 20229301, 20253901, 20558602, 20698102, 20777201 21869701, 21983904, 21995301 GTIN: 10886982297372
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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