Recall Z-1235-2024— Synthes (USA) Products LLC
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: 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S. 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
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.