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FDAFDA · Food and drugs·Recall number Z-1235-2024

1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S

Published March 13, 2024 · Recall initiated: January 24, 2024

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

Products not sterilized, sterility cannot be confirmed

What to do

Voluntary: Firm initiated · E-Mail

Recall details

Manufacturer
Synthes (USA) Products LLC
Distributor
Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
Lot
UDI: 10886982186034 Lot Number: 19P4364
Risk classification
Class II
Area (FDA)
device
Country
United States

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