Z-1236-2024 Class II Ongoing
FDA device recall Z-1236-2024 was initiated by Synthes (USA) Products LLC on January 24, 2024 and is designated Class II. Reason for recall: Products not sterilized, sterility cannot be confirmed The recall status is ongoing. Affected quantity: 30 units.
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
- 30 units
Product Description
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
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: 10886982186324 Lot Number: 77P6506