Device product
Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104
Z-0635-2022
Product summary
- Event
- Event 89443
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 271 units
- Official record key
device-enforcement:Z-0635-2022
Official wording
Reason: Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Code information: Lot Numbers: 50971615, 50971617 & 50967788
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.
Derived failure modes
-
Unknown
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process