Recall Z-1236-2024— Synthes (USA) Products LLC

Name: FDA recall Z-1236-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-24

Class II · Ongoing

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2024-01-24. FDA's recall record names no specific 510(k) clearance for this event. Product: 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S. Reason: Products not sterilized, sterility cannot be confirmed.

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-01-24
Firm location: West Chester, PA, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.