PlainRecalls
FDA Devices Moderate Class II Ongoing

2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S

Reported: March 13, 2024 Initiated: January 24, 2024 #Z-1236-2024

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

Details

Units Affected
30 units
Distribution
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.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S. Recalled by Synthes (USA) Products LLC. Units affected: 30 units.
Why was this product recalled?
Products not sterilized, sterility cannot be confirmed
Which agency issued this recall?
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1236-2024.