Z-1235-2024 Class II Ongoing

Recalled by Synthes (USA) Products LLC — West Chester, PA

Recall Details

Product Type
Devices
Report Date
March 13, 2024
Initiation Date
January 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units

Product Description

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

Reason for Recall

Products not sterilized, sterility cannot be confirmed

Distribution Pattern

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.

Code Information

UDI: 10886982186034 Lot Number: 19P4364